BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 21778998 · Received April 4, 2025

    Report

    Report Number
    2210968-2025-03588
    Event Type
    Injury
    Date Received
    April 4, 2025
    Report Date
    April 4, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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: PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE; THE PATIENTS WERE ALL PEDIATRIC PATIENTS: TEENS AND TWENTY SOMETHING YEAR OLDS. DATE AND NAME OF INDEX SURGICAL PROCEDURE? NOT AVAILABLE. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? QUAD ACL REPAIR, CRUCIATE LIGAMENT RECONSTRUCTION, MEDIAL PATELLOFEMORAL LIGAMENT RECONSTRUCTION, ETC. WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? ARTHROSCOPIC. ON WHAT TISSUE WAS THE SUTURE USED? VICRYL USED TO CLOSE EACH LAYER: 2-0 VICRYL FOR SUBCUTANEOUS AND 3-0 VICRYL FOR SUBCUTICULAR. WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? TORN BUT HEALTHY TISSUE. HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? CONTINUOUS. HOW WAS THE SUTURE TIED (SQUARE KNOT OR MULTIPLE KNOTS ONE END)? PLEASE DESCRIBE THE SEPARATION. WHAT TISSUE DEHISCED? SUBCUTICULAR. PLEASE DESCRIBE THE APPEARANCE OF THE SUTURE DURING THE SECOND PROCEDURE. DID THE SUTURE UNTIE, BREAK, OR PULL OUT OF THE TISSUE? PLEASE SPECIFY; SUTURE PULLED OUT OF TISSUE RESULTING IN HYPERTROPHIC SCAR (WIDENING OF SCAR). WERE THERE ANY PATIENT STRESS FACTORS THAT LED TO THE SUTURE UNTYING, BREAKING OR PULLING OUT OF THE TISSUE? HIGH TENSION AREA ABOVE KNEE ONSET DATE/TIME OF DEHISCENCE? (# POST OP DAYS) NOT SURE. HOW WAS THE DEHISCENCE MANAGED? NOT SURE. 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? NONE THAT WAS REPORTED. WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? HYPERTROPHIC SCAR (SCAR WIDENING). OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? NOT SURE. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? NOT SURE. WHAT IS THE PATIENT'S CURRENT STATUS? NOT SURE. PRODUCT CODE AND LOT NUMBER? NOT SURE. I DO HAVE A LIST OF 2-0 AND 3-0 VICRYL SUTURES THAT ARE ON DR. (B)(6) PREFERENCE CARD BUT THE (B)(6) IS UNSURE WHICH SUTURES WERE USED WHEN THE PATIENT HAD A DEHISCENCE. SO, I DON¿T THINK YOU WANT THOSE SUTURE CODES, CORRECT? THEY AREN¿T SURE WHICH ONES WERE USED IN THOSE PARTICULAR INSTANCES WHEN THEY GOT THE HYPERTROPHIC SCARS. THE DOCTOR HAS SWITCHED TO 3-0 MONOCRYL VS 3-0 VICRYL FOR SUBCUTICULAR LAYER RECENTLY AND FINDING BETTER RESULTS; NO DEHISCENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE STAFF SAW A SEPARATION IN THE PATIENT'S HEALING PROCESS. IT IS UNKNOWN IF THE WOUND DEHISCED WHERE THE LITTLE SCAB FORMED, OR IF THE SCAR BECAME WIDER. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658256 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other