BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON SUTURE MATERIAL

    MDR report key: 910362 · Received September 6, 2007

    Report

    Report Number
    MW5003683
    Event Type
    Malfunction
    Date Received
    September 6, 2007
    Report Date
    September 6, 2007
    Manufacturer
    ETHICON
    Product Code
    HAS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2007, FIBULA SHAFT - PRODUCT FRACTURED INTO PIECES WHILE PLACING INTO PT. GRAFT TAKEN OUT OF PT. GRAFT WAS PRE-SOAKED. 4CM PRODUCT CODE 800721. NO PACKAGING- UNKNOWN, UNKNOWN NO IR. BROKEN NEEDLE. ETHICON MONOCRYL Y399 TAPER CTX 1. ROUTE: CUTANEOUS. DATES OF USE: TWO MONTHS IN 2007. DIAGNOSIS OR REASON: SURGICAL SUTURE MATERIAL. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES. EVENT REAPPEARED AFTER REINTRODUCTION? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON SUTURE MATERIAL ETHICON SUTURE MATERIAL HAS ETHICON * *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR