BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL PLUS SUTURE

    MDR report key: 3223602 · Received July 12, 2013

    Report

    Report Number
    2210968-2013-13012
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    March 23, 2013
    Report Date
    July 3, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K050845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: SEVERAL FRAGMENTS OF SUTURE WERE RETURNED FOR EVALUATION. THE FRAGMENTS WERE FRAGILE AND COULD BE BROKEN EASILY, INDICATING SIGNIFICANT DEGRADATION AND SUGGESTING THE SUTURE PACKAGING HAD BEEN COMPROMISED. NO SUTURE PACKAGING WAS RETURNED, SO IT COULD NOT BE DETERMINED IF THE PACKAGING WAS DAMAGED, DEFECTIVE, OR IF THE PRODUCT HAD BEEN RE-STERILIZED BY THE END-USER. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION - 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 A PATIENT UNDERWENT AN ABDOMINOPLASTY ON (B)(6) 2013 AND SUTURE WAS USED. THE SUTURE BROKE WHEN IT WAS REMOVED FROM THE PACKAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322582 MONOCRYL PLUS SUTURE SUTURES - ABSORBABLE GAM ETHICON INC. UNK GBM462

    Patients

    Seq Age Sex Outcome Treatment
    1