BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 14205855 · Received April 26, 2022

    Report

    Report Number
    2210968-2022-02959
    Event Type
    Injury
    Date Received
    April 26, 2022
    Date of Event
    March 14, 2022
    Report Date
    April 26, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. THE FOLLOWING INFORMATION WAS REQUESTED BUT UNAVAILABLE: PRODUCT CODE AND LOT NUMBER? WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? WERE CULTURES PERFORMED? RESULTS? WHAT MEDICAL INTERVENTION WAS PERFORMED FOR SYMPTOMS? WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? ALL ANSWERS ABOVE ARE UNOBTAINABLE. ONCE THERE IS ANY UPDATE, WE WILL UPDATE THE INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE FOR AN OPEN REDUCTION AND INTERNAL FIXATION OF LEFT FEMORAL INTERTROCHANTERIC FRACTURE ON (B)(6) 2022 AND SUTURE WAS USED. FIVE DAYS AFTER OPERATION, THE WOUND HEALED WELL AND THE PATIENT WAS DISCHARGED FROM HOSPITAL. THEN IT WAS FOUND THAT THERE WERE SMALL COLLICULUS WITH DARK COLOR AND ITCHING AT THE EDGE OF THE WOUND, SO THE PATIENT WENT BACK TO THE HOSPITAL FOR FURTHER CONSULTATION 8 DAYS AFTER THE OPERATION. THE PATIENT POST-OP INFLAMMATION. CONSIDERING THE REACTION OF SUTURE, DISINFECTION AND PUNCTURED WITH STERILE NEEDLE. PICKED ONE SUTURE END FROM THE PUNCTURE POINT, DISINFECTED AND WRAPPED WITH STERILE GAUZE. ANOTHER DAY LATER, THE CUSTOMER CALLED BACK TO THE PATIENT AND FOUND THAT THE PATIENT RECOVERED WELL WITHOUT ADVERSE EFFECTS. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027180 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention