BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE UNKNOWN

    MDR report key: 3781032 · Received April 30, 2014

    Report

    Report Number
    2210968-2014-05468
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    April 14, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    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. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH 464500 MFR. DATE: 09/01/2013, EXP. DATE: 08/31/2018. BATCH 475910 MFR. DATE: 11/30/2013, EXP. DATE: 10/30/2018. BATCH 477923 MFR. DATE: 11/30/2013, EXP. DATE: 11/30/2018. BATCH 478535 MFR. DATE: 11/30/2013, EXP. DATE: 11/30/2018. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE POSTPARTUM PATIENT EXPERIENCED ABDOMINAL WALL INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260473 SUTURE UNKNOWN GAM ETHICON INC. UNK 464500

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention