BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE UNKNOWN

    MDR report key: 22382021 · Received July 2, 2025

    Report

    Report Number
    2210968-2025-07693
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    May 6, 2025
    Report Date
    August 14, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAO
    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). CORRECTED INFORMATION: B1, B2, H1 - IT WAS REPORTED THAT THIS IS A DUPLICATE REPORT OF 1221934-2025-03090, THEREFORE THIS MEDWATCH REPORT IS BEING VOIDED. ALL INFORMATION REGARDING THIS EVENT WILL BE CAPTURED UNDER 1221934-2025-03090.

    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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. *** BQ ¿ IN THE IP UNDER UNRECOGNIZED NUMBER, IT STATES ¿223114; 286L138¿, PLEASE CLARIFY WHAT THESE NUMBERS MEAN*** NAME/TYPE OF SUTURE USED? PRODUCT CODE AND LOT NUMBER? PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? 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)? WHAT SYMPTOMS OF POOR WOUND HEALING DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? 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?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RECONSTRUCTION SURGERY OF MEDIAL PATELLAR LIGAMENT ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT UNDERWENT SURGERY FOR PATELLAR DISLOCATION. DURING THE SURGERY, SUTURE WAS USED TO FIX THE MEDIAL SUPPORTING LIGAMENT. THE LIGAMENT WAS STABLE, THE SURGERY WENT SMOOTHLY, THE PATIENT WAS DISCHARGED. 88 DAYS AFTER THE SURGERY, THE PATIENT COMPLAINED THAT THE WOUND CONTINUED TO HEAL POORLY. THE PATIENT UNDERWENT A DEBRIDEMENT AND SUTURE AND VSD COVERING SURGERY ON (B)(6) 2025. THE WOUND HEALED WELL. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2483853 SUTURE UNKNOWN SUTURE, NONABSORBABLE GAO ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention