BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAWRAP

    MDR report key: 17845260 · Received September 29, 2023

    Report

    Report Number
    3012669262-2023-00001
    Event Type
    Injury
    Date Received
    September 29, 2023
    Date of Event
    July 13, 2023
    Report Date
    September 13, 2023
    Manufacturer
    ALAFAIR BIOSCIENCES
    Product Code
    FTM
    UDI-DI
    B4S4VTP22010
    PMA / PMN Number
    K213163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS FEEDBACK INCLUDED 1) A REVIEW OF THE FEEDBACK DETAILS, 2) A REVIEW OF THE DEVICE LOT HISTORY RECORD, 3) A REVIEW OF THE COMPLAINT DATABASE, 4) COMMUNICATION WITH THE SURGEON AND DISTRIBUTOR, AND 5) A REVIEW OF THE IFU. NO ANOMALIES WERE FOUND, THE ROOT CAUSE OF THE INFECTION IS UNLIKELY RELATED TO VERSAWRAP.

    Description of Event or Problem · 0

    ON (B)(6) 2023, USING A DA VINCI SYSTEM, A HYSTERECTOMY, APPENDECTOMY, AND PERITONECTOMY WAS PERFORMED. VERSAWRAP WAS APPLIED TO THE RAW SURFACES WHERE THE PERITONEUM WAS REMOVED. AMNIOFIX (MIMEDX) WAS ALSO USED IN THE PROCEDURE. TWO (2) WEEKS POSTOPERATIVE THE PATIENT PRESENTED WITH PAIN. MRI IDENTIFIED A 6 CM ABSCESS IN THE LOWER LEFT PELVIS. CULTURE IDENTIFIED PSEUDOMONAS. THE PATIENT WAS TREATED WITH REPEAT SURGERY AND IV ANTIBIOTICS. A REVIEW OF THE DEVICE LOT HISTORY RECORDS INDICATED THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. THE DEVICE IS PROVIDED TO THE END USER AS A STERILE DEVICE. THE DEVICE WOULD NOT CAUSE AN INFECTION. ALAFAIR BIOSCIENCES HAS A VALIDATED STERILIZATION CYCLE WITH A STERILITY ASSURANCE LEVEL OF (SAL) 10^-6. THE VALIDATED STERILITY CYCLE AND ALL PARAMETERS OF ALL DEVICES ARE VERIFIED PRIOR TO RELEASE FOR DISTRIBUTION. THE ROOT CAUSE OF THE PRESENCE OF A PELVIC ABSCESS IS INCONCLUSIVE. IN A SUBSEQUENT CONVERSATIONS WITH THE SURGEON, THE SURGEON INDICATED THAT THE PATIENT RECOVERED AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2287105 VERSAWRAP TENDON / NERVE PROTECTOR FTM ALAFAIR BIOSCIENCES VTP-2201 001240216-1001 B4S4VTP22010

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Required Intervention AMNIOFIX