BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH OVAL

    MDR report key: 5806278 · Received July 19, 2016

    Report

    Report Number
    2210968-2016-10602
    Event Type
    Injury
    Date Received
    July 19, 2016
    Report Date
    June 30, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE PATIENT DEMOGRAPHIC INFO: AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE -NO INFORMATION. WHAT IS PHYSICIANS OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? NO INFORMATION. WHAT IS THE PATIENT'S CURRENT STATUS? THE PATIENT IS STABLE AND MONITORED. WAS THE HERNIA REPAIR ASSOCIATED WITH THIS EVENT PERFORMED ON PRIMARY OR RECURRENT HERNIA? PRIMARY. IF APPLICABLE, CLOSURE OF THE DEFECT (YES OR NO), USE OF STAY SUTURES (HOW MANY), PERMANENT OR ABSORBABLE? NO DEFECT. THE TUCKER OF COMPETITIVE COMPANY AND SUTURES OF NYLON WERE USED TO FIX THE MESH. THE INTERVAL OF FIXED POINT WAS ABOUT 1CM. THE MARGIN OF MESH WAS OVER 5CM. IF APPLICABLE, THE MESH FIXATION TECHNIQUE: DEVICE AND TECHNIQUE? (SINGLE OR DOUBLE CROWN; SPACING BETWEEN IMPLANTS). NO INFORMATION. WAS THERE ANY TRIGGERING EVENT PRIOR TO PRESENT RECURRENCE? (E.G. WEIGHT GAIN, SNEEZING, COUGHING, STRENUOUS ACTIVITY)? NO INFORMATION. HAS ANY MEDICAL OR SURGICAL INTERVENTION BEEN PROVIDED FOR THE HERNIA RECURRENCE? NO SURGICAL INTERVENTION WAS PROVIDED. ARE THERE ANY PHOTOS AVAILABLE? NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IPOM HERNIA PROCEDURE ON (B)(6) 2015 AND MESH WAS IMPLANTED. POST-OPERATIVELY, THE PATIENT WAS OBSERVED REGULARLY, BUT THERE WAS NO INDICATION OF HERNIA REOCCURRENCE. THE REOCCURRENCE OF HERNIA WAS DIAGNOSED BY CT SCAN ON (B)(6) 2016. THE PATIENT IS STABLE AND MONITORED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459893 PHYSIOMESH OVAL MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK JC8HHSB0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention