In Brief, What Happened?

[[content_IBWH]]

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¿En Español: Que Pasó?

[[content_IBWH-es]]

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What are the Dates of this Event?

[[content_WDTE]]

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What Happened to Patient(s)?

[[content_WHTP]]

Note from the FDA: Certain types of report information are protected from public disclosure under the Freedom of Information Act (FOIA). If a report contains trade secret or confidential business information, that text is replaced by "(b)(4)". If a report contains personnel or medical files information, that text is replaced by "(b)(6)". The designations "(b)(4)" and "(b)(6)" refer to the exemptions in the FOIA. For example, "(b)(4)" may be found in place of the product's composition and "(b)(6)" may be found in place of a patient's age.

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Who Manufactured This Device?

[[content_WMTD]]

Manufacturer:{manufacturer_g1_name}

Manufacturer info. Also include harmonized name: [HarmonizedManufacturerName].

[ManufacturerName]

[HarmonizedManufacturerName]

Contact Details:
Main address:

38 avenue de l'Opera

F-75002

Paris, France

Tel:

(33 1) 42 68 53 00

Fax:

(33 1) 42 68 53 01

E-mail:

secretariat(at)google.org

Contact person:

Jack Daniels

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Who Distributed This Device?

[[content_WDTD]]

Distributor info. Also include harmonized name: [HarmonizedDistributorName].

[DistributorName]

[HarmonizedDistributorName]

Contact Details:
Main address:

38 avenue de l'Opera

F-75002

Paris, France

Tel:

(33 1) 42 68 53 00

Fax:

(33 1) 42 68 53 01

E-mail:

secretariat(at)google.org

Contact person:

Johnny Walker

More about this distributor

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What Kind of Device is This?

[[content_WKDIT]]

brand_name:{brand_name}


generic_name:{generic_name}


expiration_date_of_device:{expiration_date_of_device}


adverseOutcome

contraindication

indication

postOp

preOp

procedure

purpose

seriousAdverseOutcome

code

guideline

legalStatus

medicineSystem

recognizingAuthority

relevantSpecialty

study

additionalType

alternateName

description

disambiguatingDescription

image

mainEntityOfPage

name

potentialAction

sameAs

More about this device type

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Notes

[[content_NOTES]]

The MAUDE database consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19. MAUDE data is current through the end of the previous month. FDA seeks to include all reports received prior to the update. However, the inclusion of some reports may be delayed by technical or clerical difficulties. MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. Please be aware that reports regarding device trade names may have been submitted under different manufacturer names. Searches only retrieve records that contain the search term(s) provided by the requester.


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Disclaimer

Section 21 CFR 803.16 states that "A report or other information submitted by a reporting entity under this part, and any release by FDA of that report or information, does not necessarily reflect a conclusion by the party submitting the report or by FDA that the report or information constitutes an admission that the device, or the reporting entity or its employees, caused or contributed to the reportable event. The reporting entity need not admit and may deny that the report or information submitted under this part constitutes an admission that the device, the party submitting the report, or employees thereof, caused or contributed to a reportable event." In addition, some firms have submitted their own additional disclaimer statements. Source: FDA's MAUDE page.


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