BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL RAP UND 75CM M2 USP3/0 SGLE ARMED PS-2 PRIME

    MDR report key: 18660255 · Received February 7, 2024

    Report

    Report Number
    2210968-2024-01087
    Event Type
    Injury
    Date Received
    February 7, 2024
    Date of Event
    January 19, 2024
    Report Date
    March 18, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Adverse Event
    Yes
    Product Problem
    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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: RECEIVED INFORMATION AS FOLLOWING FROM SALES REP VIA PHONE TODAY. AFTER INVESTIGATION, THE PATIENT WAS A 27-YEAR-OLD FEMALE WHO UNDERWENT LATERAL EPISIOTOMY REPAIR IN HOSPITAL ON (B)(6) 2024. THE SURGEON USED (B)(6) TO PERFORM SEWING OF INTRADERMAL PERINEAL SKIN IN THE WAY OF CONTINUOUS SUTURING MANNER DURING THE OPERATION. THE SURGERY WENT SMOOTHLY. TWO HOURS AFTER THE SURGERY, THE MEDICAL STAFF FOUND THAT THE SKIN AT 1 CM BELOW THE TOP OF THE OUTERMOST INTRADERMAL SUTURE DEHISCED AND THE SUTURE BROKE DURING INTRAVAGINAL EXAMINATION. THE PATIENT WAS IMMEDIATELY GIVEN A SECOND LOCAL ANESTHESIA AND THEN RE-SUTURED WITH SILK SUTURE. THE WOUND RECOVERY OF THE PATIENT WAS IMPROVED CURRENTLY. NO SUBSEQUENT ADVERSE EVENT REPORT WAS RECEIVED.

    Additional Manufacturer Narrative · 0

    (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. ADDITIONAL INFORMATION: H6 TYPE OF INVESTIGATION A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE FOLLOWING INFORMATION WAS REQUESTED BUT UNAVAILABLE: IT WAS REPORTED ¿THERE IS LOOSENESS IN THE FINAL KNOT¿ - DID THE FINAL KNOT UNTIE? -OR- WAS THE FINAL KNOT LOOSE DUE TO THE SUTURE BREAKAGE? PLEASE PROVIDE THE PATIENT'S WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? HOW WAS THE SUTURE TIED (SQUARE KNOT OR MULTIPLE KNOTS ONE END)? DID THE PATIENT EXPERIENCE A WOUND DEHISCENCE? WERE THERE ANY PATIENT STRESS FACTORS THAT PRECIPITATED THE EVENT OF SUTURE BREAKAGE POST OP? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? PLEASE DESCRIBE THE APPEARANCE OF THE SUTURE DURING THE SECOND PROCEDURE. WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? 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?

    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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED 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. IT WAS REPORTED ¿THERE IS LOOSENESS IN THE FINAL KNOT¿ - DID THE FINAL KNOT UNTIE? -OR- WAS THE FINAL KNOT LOOSE DUE TO THE SUTURE BREAKAGE? PLEASE PROVIDE THE PATIENT'S WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? HOW WAS THE SUTURE TIED (SQUARE KNOT OR MULTIPLE KNOTS ONE END)? DID THE PATIENT EXPERIENCE A WOUND DEHISCENCE? WERE THERE ANY PATIENT STRESS FACTORS THAT PRECIPITATED THE EVENT OF SUTURE BREAKAGE POST OP? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? PLEASE DESCRIBE THE APPEARANCE OF THE SUTURE DURING THE SECOND PROCEDURE. WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? 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? RELATED MEDWATCH REPORTS: 2210968-2024-01088.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LATERAL PERINEAL INCISION TO ASSIST IN DELIVERING A LIVE BABY ON (B)(6)2024 AND ROUTINE PERINEAL CONTINUOUS SUTURE WAS USED. BEFORE RETURNING TO THE WARD 2 HOURS POSTPARTUM, A VAGINAL EXAMINATION WAS CONDUCTED AGAIN, AND IT WAS FOUND THAT THE OUTERMOST LAYER OF THE INTRADERMAL SUTURE WAS CRACKED 1CM BELOW THE TOP, AND BROKEN SUTURE WAS SEEN TO BE RETRACTED DUE TO TENSION. AT THE SAME TIME, THERE IS LOOSENESS IN THE FINAL KNOT SUTURE WHEN PULLING, AND THEN THERE IS CRACKING WHEN PRESSING AGAIN AT THE BEGINNING OF THE FIRST STITCH. IMMEDIATELY PERFORM LOCAL ANESTHESIA AGAIN AND PERFORM 3 STITCHES TO RE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365680 VICRYL RAP UND 75CM M2 USP3/0 SGLE ARMED PS-2 PRIME SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. AU4076

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Required Intervention