BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 21854107 · Received April 17, 2025

    Report

    Report Number
    2210968-2025-03481
    Event Type
    Injury
    Date Received
    April 17, 2025
    Date of Event
    November 26, 2024
    Report Date
    April 17, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. H6 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. (B)(4) - MW5167511, EVENT DATE 1-OCT-2024, 75-YEAR-OLD MALE (B)(4) - MW5167514, EVENT DATE 6-NOV-2024, 64-YEAR-OLD FEMALE (B)(4) - MW5167516, EVENT DATE 31-DEC-2024, 79-YEAR-OLD FEMALE (B)(4) - MW5167518, EVENT DATE 22-NOV-2024, 76-YEAR-OLD FEMALE (B)(4) ¿ MW5167506, EVENT DATE 12-NOV-2024, 76-YEAR-OLD FEMALE (B)(4) - MW5167508, EVENT DATE 20-NOV-2024, 69-YEAR-OLD FEMALE (B)(4) ¿ MW5167509, EVENT DATE 11-DEC-2024, 48-YEAR-OLD FEMALE PLEASE PROVIDE THE FOLLOWING INFORMATION FOR EACH PATIENT: 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? 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 ORIGINALLY TIED (MULTIPLE KNOTS, SQUARE KNOT, ETC.)? WHAT TISSUE DEHISCED? IS IT KNOWN HOW THE WOUND DEHISCED? DID THE SUTURE PULL OUT OF THE TISSUE? DID THE SUTURE BREAK? IF SO, WHERE WAS THE BREAK NOTED? WERE THERE ANY PATIENT STRESS FACTORS THAT PRECIPITATED THIS EVENT? ONSET DATE/TIME OF DEHISCENCE? (# POST OP DAYS) 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. 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? PRODUCT CODE AND LOT NUMBER? WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THERE WAS DEHISCENCE OF SURGICAL INCISION. THE PATIENT REQUIRED INTERVENTION. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114988 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention