BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL RAPIDE

    MDR report key: 6136139 · Received November 30, 2016

    Report

    Report Number
    2210968-2016-15215
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 10, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EPISIOTOMY PROCEDURE ON UNKNOWN DATE AND CONTINUOUS SUTURE WAS USED IN THE PERINEAL SKIN LAYER. FOLLOWING THE PROCEDURE, THE SUTURE WAS TOTALLY ABSORBED WITHIN A WEEK AFTER SURGERY AND WOUND DEHISCENCE WAS OBSERVED ON THE SIXTH OR SEVENTH DAY POST-OP. IT WAS ALSO REPORTED THAT THE WOUND OPENING LOOKS LIKE IT GOES BELOW THE SKIN. THE PATIENT UNDERWENT A LATERAL PERINEAL REPAIR ON (B)(6) 2016 AND ANOTHER SUTURE WAS USED TO RE-SUTURE THE WOUND. THE PATIENT IS STILL IN THE HOSPITAL FOR FURTHER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784947 VICRYL RAPIDE SUTURE, ABSORBABLE, NATURAL GAM ETHICON INC. UNK AE3833

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R