BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 6102535 · Received November 15, 2016

    Report

    Report Number
    2210968-2016-60080
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 17, 2016
    Report Date
    October 27, 2016
    Manufacturer
    JOHNSON & JOHNSON INTERNATIONAL
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SUTURE SAMPLES WERE EXAMINED FOR VISUAL INSPECTION, KNOT PULL TEST AND IN-VITRO PULL TEST AND THE REPRESENTATIVE SAMPLES MET THE SPECIFIED QUALITY REQUIREMENTS AND VERIFIED TO MEET THE ABSORPTION PROFILE OF VICRYL SUTURES.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. ADDITIONAL INFORMATION WAS OBTAINED: IS THE COMPLAINT ID: (B)(4) AND (B)(4) DUPLICATE COMPLAINTS - TWO DIFFERENT ANIMALS. IS THE COMPLAINT ID: (B)(4) AND (B)(4) THE SAME ANIMAL OR DIFFERENT ANIMAL - TWO DIFFERENT ANIMALS. THE EVENT DESCRIPTION INDICATES THAT FIVE DAYS AFTER SURGERY THE SUTURE WAS FOUND BROKEN. PLEASE EXPLAIN WHY THE COMPLAINT FORM INDICATES THAT THE EVENT OCCURRED DURING USE - IT WAS A MISTAKE. THE THREADS WERE BROKEN 5 DAYS AFTER SURGERY DID THE SUTURE BREAKAGE OCCUR INTRA-OP SUTURE BREAKAGE OR POST OP - POST-OP THE RETURNED SUTURE SAMPLES WERE EXAMINED FOR VISUAL INSPECTION, KNOT PULL TEST AND IN-VITRO PULL TEST AND THE REPRESENTATIVE SAMPLES MET THE SPECIFIED QUALITY REQUIREMENTS AND VERIFIED TO MEET THE ABSORPTION PROFILE OF VICRYL SUTURES.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT TO FDA: 11/15/2016. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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 AN ANIMAL UNDERWENT A CAESAREAN PROCEDURE ON (B)(6) 2016 AND SUTURE WAS USED. THE VETERINARIAN MADE A RUNNING SUTURE OF THE ABDOMINAL WALL AND THE SUBCUTANEOUS TISSUE. FIVE DAYS AFTER SURGERY, IT WAS FOUND THAT THE SUTURE WAS BROKEN. ANOTHER LIKE DEVICE WAS USED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753625 VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM JOHNSON & JOHNSON INTERNATIONAL UNK KE8CCRQ0

    Patients

    Seq Age Sex Outcome Treatment
    1