BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

    MDR report key: 3083048 · Received April 29, 2013

    Report

    Report Number
    2210968-2013-04661
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAS
    PMA / PMN Number
    N17804
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    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 ACCOUNT REPORTS THE FOLLOWING POSSIBLE BATCH NUMBER: BATCH DPP466 MFG DATE: 12/01/2011, EXP DATE: 07/31/2016. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-04660. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. APPROXIMATELY 4 TO 6 WEEKS POST-OPERATIVELY, THE PATIENT EXPERIENCED SPITTING OF THE SUTURE AT THE UMBILICUS . THE PATIENT UNDERWENT A SECOND SURGERY TO REMOVE THE SUTURES. DURING THE PROCEDURE, GRANULOMA FORMATION AND TISSUE BREAKDOWN WERE FOUND. ADDITIONAL INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185258 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE SUTURE, NON-ABSORBABLE GAS ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention