BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK BRD BLK 15X60CM M1.5

    MDR report key: 15849008 · Received November 22, 2022

    Report

    Report Number
    2210968-2022-09734
    Event Type
    Injury
    Date Received
    November 22, 2022
    Date of Event
    October 22, 2022
    Report Date
    January 6, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. DEVICE NOT RETURNED. THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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. PLEASE CLARIFY WHAT IS MEANT BY HERPES? AFTER THE SUTURES WERE REMOVED ON THE FIFTH DAY, WAS THE PATIENT RE-SUTURED? PLEASE CLARIFY THE DATE OF THE PROCEDURE. (B)(6) 2022? PLEASE CLARIFY THE DATE OF THE EVENT. (B)(6) 2022? (EVENT CANNOT OCCUR PRIOR TO THE PROCEDURE). PLEASE PROVIDE THE PATIENT'S WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THIS SUTURE EVENT INCLUDING DATES AND RESULTS. WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFLAMMATION/INFECTION PRIOR TO THIS SURGICAL PROCEDURE? WERE CULTURES PERFORMED? RESULTS? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? IF APPLICABLE, WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A DEBRIDEMENT AND SUTURE DUE TO THE PATIENT ACCIDENTALLY FELL DOWN AND CAUSED BRUISES AND BLEEDING IN HIS RIGHT CALF ON (B)(6) 2022 AND SUTURE WAS USED. ON THE THIRD DAY, IT WAS FOUND THAT THERE WAS INFLAMMATION, REDNESS, SWELLING AND HERPES AROUND THE SUTURE SITE. AFTER INTRAVENOUS INFUSION OF AMOXICILLIN AND CLAVULANATE POTASSIUM INJECTION FOR 2 DAYS, THE SWELLING DID NOT SUBSIDE. ON THE FIFTH DAY, THE SUTURE WAS REMOVED INTERMITTENTLY. THE NEXT DAY, IT WAS CHECKED THAT THE REDNESS AND SWELLING OF THE SUTURE SITE WERE ALLEVIATED AND THERE WAS NO HERPES. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354682 SILK BRD BLK 15X60CM M1.5 SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. PG4AF

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention