BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 16454215 · Received February 28, 2023

    Report

    Report Number
    2210968-2023-01368
    Event Type
    Injury
    Date Received
    February 28, 2023
    Date of Event
    February 20, 2023
    Report Date
    February 28, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. COMPONENT CODE: G07002 DEVICE NOT RETURNED ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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. PLEASE CLARIFY PROCEDURE DATE/ EVENT DATE. BOTH WERE REPORTED AS 2/20/23. (DEHISCENCE WAS REPORTED 7DAYS LATER) PLEASE CLARIFY WHICH TYPE OF SUTURE WAS USED. PRODUCT CODE AND LOT NUMBER? PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, 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)? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? HOW WAS THE SUTURE TIED (SQUARE KNOT OR MULTIPLE KNOTS ONE END)? WHAT TISSUE DEHISCED? IS IT KNOWN HOW THE WOUND DEHISCED? DID THE SUTURES UNTIE, BREAK, OR PULL OUT OF THE TISSUE? WERE THERE ANY PRECIPITATING STRESS FACTORS THAT LED TO THE SUTURE UNTYING, BREAKING OR PULLING OUT OF THE TISSUE? HOW WAS THE DEHISCENCE MANAGED? PLEASE DESCRIBE ANY SURGICAL INTERVENTION REQUIRED FOR THE WOUND DEHISCENCE INCLUDING DATE AND FINDINGS. 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? IF APPLICABLE, WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION. SURGEON¿S NAME?

    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: A2, A3, A4, B2, B7, D1, D2, E1, H6 ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: PATIENT ¿ ST, DOB 3/23/1991, AGE AT BIRTH 31, BMI 33.36 C SECTION WITH SPINAL ANESTHESIA - DATE (B)(6) 2023 ¿ CAVITY NORMAL UTERINE CLOSURE WITH VICRYL 1, 2 LAYERS.2 SUTURES USED. SKIN CLOSURE- CONTINUOUS SUBCUTICULAR CLOSURE WITH MONOCRYL. LEUKOMED SORBACT DRESSING APPLIED. NO INTRAOPERATIVE COMPLICATIONS. WOUND DEHISCENCE OCCURRED ON (B)(6) 2023. PATIENT UNDERWENT REPAIR OF WOUND DEHISCENCE. BOWEL LOOPS INSPECTED THOROUGHLY, HEALTHY PINK, VIABLE TISSUE, NO GANGRENOUS SEGMENT FOUND. C/S SCAR CHECKED - NIL ACTIVE BLEEDING. WARM SALINE WASH GIVEN. BOWEL LOOPS REPOSITED. SHEATH CLOSED USING LOOP PDS INTERRUPTED SUTURES PLACED IN SUBCUTANEOUS FAT USING VICRYL. SKIN CLOSED USING STAPLERS MINIMAL EBL (ESTIMATED BLOOD LOSS) PROCEDURE UNEVENTFUL RELATED MEDWATCH REPORTS: 2210968-2023-01981, 2210968-2023-01982

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A C SECTION ON (B)(6) 2023 AND SUTURE WAS USED. THE PATIENT EXPERIENCED WOUND DEHISCENCE 7 DAYS AFTER HER C-SECTION. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24432 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.
    409574 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention| O