BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK BRD BLK 15X60CM M2.0

    MDR report key: 9475665 · Received December 16, 2019

    Report

    Report Number
    2210968-2019-90959
    Event Type
    Malfunction
    Date Received
    December 16, 2019
    Date of Event
    November 18, 2019
    Report Date
    November 24, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 01/15/2020.

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 01/15/2020. THE DEVICE HISTORY RECORDS REVIEWED, AND NO ISSUE FOUND. H-3 SUMMARY: ACTUAL COMPLAINT SAMPLE CAN'T BE RETURNED. THE RETAINED SAMPLES HAVE BEEN EVALUATED BY APPEARANCE AND KNOT PULL TENSILE STRENGTH AND NO ISSUE FOUND. THE ROOT CAUSE OF COMPLAINT CAN'T BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED. DURING USE, THE SUTURE BROKE. ANOTHER LIKE SUTURE WAS USED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269262 SILK BRD BLK 15X60CM M2.0 SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. MM1AT

    Patients

    Seq Age Sex Outcome Treatment
    1