BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN

    MDR report key: 24712608 · Received March 30, 2026

    Report

    Report Number
    2210968-2026-03203
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    January 1, 2026
    Report Date
    March 27, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. 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 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? WERE ANY CONCOMITANT PROCEDURES PERFORMED? 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)? FOR THE ORIGINAL INTENDED CLOSURE, HOW WERE ALL LAYERS CLOSED? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? HOW WAS THE SUTURE ORIGINALLY TIED (MULTIPLE KNOTS, SQUARE KNOT, ETC.)? PLEASE DESCRIBE THE PATIENT MANIFESTATIONS OF THE REPORTED REACTION (LOCATION, SEVERITY, APPEARANCE, GENERALIZED OR LOCAL REACTION). IF GENERALIZED REACTION, PLEASE PROVIDE EACH LOCATION, SEVERITY AND APPEARANCE. PLEASE PROVIDE THE ONSET DATE/TIME OF THE REACTION FROM THE INITIAL PROCEDURE. PLEASE DESCRIBE ANY MEDICAL INTERVENTION REQUIRED TO TREAT THE PATIENT CONDITION INCLUDING MEDICATION NAME AND RESULTS. HAS THE PATIENT UNDERGONE A SECOND PROCEDURE TO REMOVE THE SCAR TISSUE FROM THE FIRST SURGERY? IF YES, PLEASE PROVIDE DATE AND RESULTS. 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 ANY PRE-OP CLEANSING PROCEDURES CHANGED RECENTLY? IF YES, PLEASE DESCRIBE. DID THE PATIENT UNDERGO A PATCH TEST? 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? PRODUCT CODE AND LOT NUMBER FOR THE VICRYL SUTURE? PRODUCT CODE AND LOT NUMBER FOR THE MONOCRYL SUTURE? PRODUCT CODE AND LOT NUMBER FOR THE ETHICOND SUTURE? WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE ADDRESS TO WHERE A SHIPPER KIT CAN BE SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST REDUCTION ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT DEVELOPED WOUND HEALING PROBLEMS ALONG ALL OF THE SUTURE LINES. LABORATORY EVALUATION DEMONSTRATED LATER THAT PATIENT HAS ALPHA-GAL. THE PATIENT NOW NEEDS REVISION SURGERY TO REMOVE THE SCAR TISSUE FROM THE FIRST SURGERY. THE PATIENT DOES NOT WISH TO HAVE ANY "INTERNAL" SUTURES, BUT THEY ARE NOT SURE IF THAT IS POSSIBLE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774857 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention