BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VCL CT BRD UD 27IN 4-0 S/A FS-2

    MDR report key: 14824892 · Received June 26, 2022

    Report

    Report Number
    2210968-2022-04869
    Event Type
    Injury
    Date Received
    June 26, 2022
    Date of Event
    May 10, 2022
    Report Date
    September 13, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031039735
    PMA / PMN Number
    K022269
    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. (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. PLEASE PROVIDE THE PATIENT'S WEIGHT AND 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. 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? PLEASE DESCRIBE THE PATIENT MANIFESTATIONS OF THE REPORTED INFECTION (LOCATION, SEVERITY, APPEARANCE, SYSTEMIC OR LOCAL INFECTION). WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? WERE CULTURES PERFORMED? IF SO, PLEASE PROVIDE THE RESULTS. WHAT IS THE PATIENT'S CURRENT STATUS? IF APPLICABLE, WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION.

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT TO THE FDA: 7/21/2022 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. ADDITIONAL INFORMATION: B7 ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PLEASE PROVIDE THE PATIENT'S WEIGHT AND BMI AT THE TIME OF INDEX PROCEDURE. ----UNABLE TO PROVIDE ON WHAT TISSUE WAS THE SUTURE USED? -- --SKIN WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? ----SECRETION OF TISSUE FLUID, POOR HEALING PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THIS SUTURE EVENT INCLUDING DATES AND RESULTS. ----ROUTINE PREPARATION BEFORE CESAREAN SECTION DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? ----NONE OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? ----NONE WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? ----A VARIETY OF FACTORS LEAD TO WOUND INFECTION. THE PATIENT IS OBESE. THE PROBABLE RATE IS POOR HEALING CAUSED BY FAT LIQUEFACTION PLEASE DESCRIBE THE PATIENT MANIFESTATIONS OF THE REPORTED INFECTION (LOCATION, SEVERITY, APPEARANCE, SYSTEMIC OR LOCAL INFECTION). ----LOCAL INFECTION WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? ----NO DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? ----PREVENTIVE MEASURES OF ANTIBIOTIC INTRAVENOUS INFUSION BEFORE OPERATION WERE CULTURES PERFORMED? IF SO, PLEASE PROVIDE THE RESULTS. ----YES, NO RESULTS AVAILABLE WHAT IS THE PATIENT'S CURRENT STATUS? ----NO RE VISIT, UNABLE TO TRACE THE CURRENT STATUS OF THE PATIENT IF APPLICABLE, WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION. ----NO

    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 HISTORY LOT : A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE QLMDZZ/J422H13 BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2022 AND SUTURE WAS USED. THE PATIENT RECOVERED AND WAS DISCHARGED ON THE 5TH DAY AFTER SURGERY . ON THE 15TH DAY AFTER SURGERY , THE PATIENT FOUND A LITTLE EXUDATION AT THE ABDOMINAL OPERATION PORT AND WENT TO THE HOSPITAL FOR EXAMINATION. IT CAN BE SEEN THAT 1/4 OF THE ABDOMINAL SURGICAL SITE IS RED, WITH LIGHT YELLOW SECRETION FLOWING OUT. AFTER THE DOCTOR GIVES THE SECRETION BACTERIAL CULTURE + DRUG SENSITIVITY EXAMINATION, THE WOUND DRESSING IS CHANGED. EXTERNAL APPLICATION OF BAIDUOBANG, ABDOMINAL INCISION FREQUENCY SPECTRUM AND STRENGTHENING ANTI-INFLAMMATORY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171591 VCL CT BRD UD 27IN 4-0 S/A FS-2 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. J422H QLMDZZ 10705031039735

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Required Intervention