BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE MESH UNKNOWN

    MDR report key: 5193223 · Received October 30, 2015

    Report

    Report Number
    2210968-2015-17042
    Event Type
    Injury
    Date Received
    October 30, 2015
    Report Date
    April 15, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 4/25/2016. IN ADDITION, LOT 1117116 WAS UNAVAILABLE FOR REVIEW THEREFORE AN ASSESSMENT MEMO WAS ATTACHED FOR PRODUCT CODE 810041B. PRODUCT CODE WAS CORRECTED FROM 810041 TO 810041B.

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND AN UNKNOWN MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNSPECIFIED INJURIES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720860 GYNECARE MESH UNKNOWN OTN ETHICON INC. UNK 1117116

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention