BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK BLK 10X30IN 0 NON NDL

    MDR report key: 8847770 · Received July 31, 2019

    Report

    Report Number
    2210968-2019-84945
    Event Type
    Injury
    Date Received
    July 31, 2019
    Date of Event
    June 17, 2019
    Report Date
    July 4, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    UDI-DI
    10705031050297
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORDS REVIEWED, AND NO ISSUE FOUND. INVESTIGATION SUMMARY: ACTUAL COMPLAINT SAMPLE CANNOT BE RETURNED. MANUFACTURING AND BATCH RECORDS HAVE BEEN REVIEWED AND WE FOUND THAT THE RELATED PRODUCT CODE WITH KL1BC IS SA86G INSTEAD OF REPORTED SA84G. 5 PACKS MANUFACTURER RETAINED SAMPLES HAVE BEEN EVALUATED BY APPEARANCE AND KNOT PULL TENSILE STRENGTH AND NO ISSUE FOUND. THE ROOT CAUSE OF COMPLAINT CAN'T BE DETERMINED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED? THE PATIENT DEMOGRAPHIC INFO: AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE; (B)(6) YEARS OLD, MALE. DATE AND NAME OF INDEX SURGICAL PROCEDURE; THE SUTURE WAS USED TO FIX ABDOMINAL. DRAINAGE TUBE ON THE ABDOMINAL SKIN. ON WHAT TISSUE WAS THE SUTURE USED? ABDOMINAL SKIN. WHAT THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? NORMAL. HOW WAS THE SUTURE PLACED, INTERRUPTED OR CONTINUOUS? UNK. DID THE SUTURE BREAK INTRA-OPERATIVELY DURING THE INITIAL PROCEDURE? THE SUTURE WAS USED TO FIX ABDOMINAL DRAINAGE TUBE ON (B)(6). DID THE SUTURE BREAK POST-OPERATIVELY AFTER THE INITIAL PROCEDURE? IT BROKE ON (B)(6) IF THE SUTURE BROKE POST-OPERATIVELY, HOW MANY DAYS POST-OPERATIVELY DID THE SUTURE BREAK AND WHAT WAS THE DATE OF REOPERATION? 3DAYS, ON (B)(6), THE PATIENT HAD BED REST, SUTURE WHICH WAS USED TO FIX ABDOMINAL DRAINAGE TUBE WAS LOOSENED, THE ABDOMINAL DRAINAGE TUBE WAS SLIPPED, AND THERE WAS RED LIQUID EXUDATION AT THE PLACEMENT SITE. THE INCISION WAS SEWED, AND THE DRESSING WAS CHANGED. AND STOP THE BLEEDING BY COMPRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED TO FIX ABDOMINAL DRAINAGE TUBE ON THE ABDOMINAL SKIN. THE PATIENT HAD BED REST . THE SUTURE WHICH WAS USED TO FIX ABDOMINAL DRAINAGE TUBE WAS LOOSENED ON (B)(6) 2019. IT WAS REPORTED THAT THE SUTURE BROKE AND LED TO THE ABDOMINAL DRAINAGE TUBE SLIPPING, AND THERE WAS RED LIQUID EXUDATION AT THE PLACEMENT SITE. THE INCISION WAS SEWED, AND THE DRESSING WAS CHANGED, AND BLEEDING STOPPED BY COMPRESSION. THE CURRENT PATIENT STATUS IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641498 SILK BLK 10X30IN 0 NON NDL SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. KL1BC 10705031050297

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention