BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL PLUS UD 27IN USP4-0

    MDR report key: 19055790 · Received April 5, 2024

    Report

    Report Number
    2210968-2024-03958
    Event Type
    Injury
    Date Received
    April 5, 2024
    Date of Event
    January 1, 2024
    Report Date
    April 5, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K050845
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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. TRADE NAME - IRGACARE®; ACTIVE INGREDIENT(S) ¿ TRICLOSAN; DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL; STRENGTH ¿ = 2360 G/M. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. 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. WERE ALL 7 LOT NUMBERS USED ON EACH PATIENT? OR IS THE EXACT LOT NUMBER UNKNOWN AND THE 7 LOTS INVOLVED ARE POSSIBLE LOT NUMBERS USED ON THE PATIENTS? FOR EACH PATIENT PLEASE SPECIFY THE PRODUCT CODE/LOT # AND QUANTITY USED. HOW MANY PATIENTS EXPERIENCED SUBCUTANEOUS INFLAMMATION? HOW MANY PATIENTS EXPERIENCED BROKEN THREADS AND WOUND DEHISCENCE? IN THE ATTACHMENT, WHAT DOES 3UV, 2UV, 1UV MEAN? 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 PLACED (INTERRUPTED OR CONTINUOUS)? HOW WAS THE SUTURE TIED (SQUARE KNOT OR MULTIPLE KNOTS ONE END)? WHAT TISSUE DEHISCED? PLEASE DESCRIBE THE APPEARANCE OF THE SUTURE DURING THE SECOND PROCEDURE? ONSET DATE/TIME OF DEHISCENCE? (# POST OP DAYS) WERE THERE ANY PATIENT STRESS FACTORS THAT PRECIPITATED THE EVENT OF SUTURE BREAKAGE POST OP? 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? WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFLAMMATION PRIOR TO THIS SURGICAL PROCEDURE? WERE ANY PRE-OP CLEANSING PROCEDURES CHANGED RECENTLY? IF YES, PLEASE DESCRIBE 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. RELATED MEDWATCH REPORTS: 2210968-2024-03957, 2210968-2024-03958, 2210968-2024-03959, 2210968-2024-03960, 2210968-2024-03961, 2210968-2024-03962, 2210968-2024-03963

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT RETURNED AFTER 2 WEEKS, WITH SUBCUTANEOUS INFLAMMATION AND THREADS THAT HAVE BROKEN (WOUND DEHISCENCE). ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447763 MONOCRYL PLUS UD 27IN USP4-0 SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM ETHICON INC. THMLUD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other