BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL STAINLESS STEEL SUTURE

    MDR report key: 1578096 · Received January 8, 2010

    Report

    Report Number
    2210968-2010-00024
    Event Type
    Injury
    Date Received
    January 8, 2010
    Report Date
    December 9, 2009
    Manufacturer
    ETHICON, INC.
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH MLJ053, MFG DATE: 10/01/1999, EXP DATE: 07/31/2004. BATCH MME362, MFG DATE: 11/01/1999, EXP DATE: 07/31/2004. BATCH MME706, MFG DATE: 11/01/1999, EXP DATE: 07/31/2004. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED, AND THE BATCHES MET ALL FINISHED GOOD RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A MEDIAN STERNOTOMY CLOSURE PROCEDURE NINE YEARS AGO. IN 2009, THE PATIENT EXPERIENCED INFLAMMATION AND DEVELOPED FISTULA AROUND WHERE THE PRODUCT WAS USED. ONE STEEL SUTURE WAS REMOVED FROM THE PATIENT THE SAME MONTH, AND A STEROID AND AN ANTIBIOTIC WERE PRESCRIBED. THE PATIENT UNDERWENT ALLERGY TESTING AND THE PATIENT HAD AN ALLERGIC REACTION TO NICKEL, THE PLATINUM, AND PALLADIUM. IT IS POSSIBLE THAT 4 OR 5 SUTURES STILL REMAIN IN THE PATIENT'S BODY. AT THIS TIME, THERE ARE NO SIGNS OF INFLAMMATION AT THE STEEL SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL STAINLESS STEEL SUTURE SUTURE, NON-ABSORBABLE GAQ ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention