BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 6253816 · Received January 16, 2017

    Report

    Report Number
    2210968-2017-30222
    Event Type
    Malfunction
    Date Received
    January 16, 2017
    Date of Event
    November 15, 2016
    Report Date
    January 3, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT TISSUE LOCATION OF THE PLACEMENT OF SUTURE? CUTANEOUS, LINEA ALBA AND SUBCUTANEOUS. WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? NORMAL. HOW WAS SUTURE INITIALLY PLACED (INTERRUPTED OR CONTINUOUS)? CONTINUOUS. HOW THE SUTURE WAS INITIALLY TIED? FIVE THROWS START AND FINISH. WAS THERE ANY PRECIPITATING STRESS FACTOR FOR THE SUTURES UNTYING, BREAKAGE OR PULLING OUT OF THE TISSUE? NO. WAS THE SUTURE REPROCESSED (IE. RE-STERILIZED) BEFORE USE? NO. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT AND DURING ANY RE-OPERATION? BROKEN MID-SUTURE LINE IN LEAN ALBA AND SUBCUTANEOUS LINE WITHIN 24 HOURS. KNOTS INTACT.

    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT TISSUE LOCATION OF THE PLACEMENT OF SUTURE? WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? HOW WAS SUTURE INITIALLY PLACED (INTERRUPTED OR CONTINUOUS)? HOW THE SUTURE WAS INITIALLY TIED? WAS THERE ANY PRECIPITATING STRESS FACTOR FOR THE SUTURES UNTYING, BREAKAGE OR PULLING OUT OF THE TISSUE? WAS THE SUTURE REPROCESSED (IE. RE-STERILIZED) BEFORE USE? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT AND DURING ANY RE-OPERATION?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2016 AND THE SUTURE WAS USED. UPON RE-OPENING THE INCISION, IT WAS NOTED THAT THE SUTURE OF THE LINEA ALBA AND SUBCUTANEOUS TISSUE HAD BROKEN MIDWAY BETWEEN THE KNOTS AT THE CRANIAL AND CAUDAL END OF THE CLOSURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36111 PDS II (POLYDIOXANONE) SUTURE SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. UNK KD6754

    Patients

    Seq Age Sex Outcome Treatment
    1