BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VCL CT BRD VIO 27IN 4-0 S/A RB-1

    MDR report key: 20368691 · Received October 4, 2024

    Report

    Report Number
    2210968-2024-10527
    Event Type
    Injury
    Date Received
    October 4, 2024
    Date of Event
    January 1, 2024
    Report Date
    October 4, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031038615
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. 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. WAS THE SUTURE EXPECTED TO BE ABSORBED AT 4 WEEKS? ABSORPTION FOR VICRYL SUTURE IS ESSENTIALLY COMPLETE BY 56-70 DAYS. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. DATE AND NAME OF INDEX SURGICAL PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL 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 ORIGINALLY TIED (MULTIPLE KNOTS, SQUARE KNOT, ETC.)? PLEASE DESCRIBE ANY MEDICAL AND/OR 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? PLEASE DESCRIBE THE PATIENT MANIFESTATIONS OF THE REPORTED REACTION (LOCATION, SEVERITY, APPEARANCE, SYSTEMIC OR LOCAL REACTION). PLEASE PROVIDE THE ONSET DATE/TIME OF THE REACTION FROM THE INITIAL PROCEDURE. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? DOES THE PATIENT HAVE A KNOWN ALLERGIC HISTORY TO ANY MEDICAL DEVICES, FOOD AND/OR MEDICATION? WAS ALLERGY TESTING PERFORMED? IF SO, PLEASE DESCRIBE WITH RESULTS. ARE THERE ANY PHOTOS AVAILABLE? WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFLAMMATION/INFECTION PRIOR TO THIS SURGICAL PROCEDURE? WERE CULTURES PERFORMED? RESULTS? WERE ANY PRE-OP CLEANSING PROCEDURES OR PRODUCTS CHANGED RECENTLY? IF YES, PLEASE DESCRIBE. ANY OTHER FACILITY OR STAFF CHANGES MADE RECENTLY? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? WILL ANY PRODUCT BE RETURNED FOR EVALUATION? SURGEON¿S NAME?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. LATER, IT WAS NOTICED THAT THE SUTURES USED WERE NOT DEGRADING AS QUICKLY AS USUAL, CAUSING A FOREIGN BODY REACTION IN THE OROPHARYNGEAL PILLARS. THE PATIENT MAY HAVE AN INTENSE CASE THAT WILL BE TAKEN TO THE OPERATING ROOM TO REMOVE SUTURES. THE PATIENT IS GENERATING AN INTENSE INFLAMMATORY REACTION WITH FOUL SECRETION AND ERYTHEMA OF THE AREA AROUND THE SUTURE 4 WEEKS AFTER SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704080 VCL CT BRD VIO 27IN 4-0 S/A RB-1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. AU7868 10705031038615

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention