BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVOSORB

    MDR report key: 17563126 · Received August 17, 2023

    Report

    Report Number
    3004504732-2022-00002
    Event Type
    Injury
    Date Received
    August 17, 2023
    Report Date
    November 25, 2022
    Manufacturer
    POLYGANICS
    Product Code
    FTL
    PMA / PMN Number
    K042811
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SEROMA DEVELOPED INITIALLY, BUT THE PAIN HAD BEEN REDUCED. RETURN OF SENSATION COULD TAKE LONGER DUE TO PHYSIOLOGICAL SYSTEMS. IT IS EXPECTED THAT VIVOSORB WOULD BE RESORBED IN THE PERIOD OF TIME (15 MONTHS, THE PRODUCT SHOULD HAVE BEEN DEGRADED WITHIN APPROX 16 MONTHS; THEREFORE NO WELL-DEFINED SHEET). NO CAUSAL RELATIONSHIP HAS BEEN ESTABLISHED BETWEEN THE INCIDENT AND THE DEVICE, AS A SEROMA IS GENERALLY ASSUMED TO BE CAUSED BY A SURGICAL PROCEDURE ITSELF AND NOT INHERENTLY RELATED TO DEVICE USE. HOWEVER, A CAUSAL RELATIONSHIP CANNOT BE RULED OUT AS THERE IS STILL PRODUCT MATERIAL IN PLACE AT THE LOCATION AND THE SEROMA REMAINED FOR AN EXTENDED TIME AFTER SURGERY.

    Description of Event or Problem · 0

    EVENT WITH VIVOSORB IN THE UK: PATIENT, 27 YR OLD, HAD GLASS LACERATION R 3RD COMMON DIGITAL NERVE (CDN) , PIN NERVE GRAFT IN 2013., RESULTING IN PAIN, NUMBNESS. (B)(6) 2021 PATIENT UNDERWENT NEUROLYSIS 3RD CDN R PALM, VIVOSORB. (B)(6) 2021 SEROMA WAS NOTED, PAIN RESOLVED, NO IMPROVED SENSATION. LUMP IN PALM. ENLARGED CAUSING FUNCTIONAL PROBLEM. (B)(6) 2022 SEROMA ASPIRATION. (B)(6) 2022 REMOVAL OF WRAP AND ENCAPSULATED SEROMA DENSE LAYER OF SCAR FOUND WITHOUT A WELL DEFINED SHEET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247108 VIVOSORB BIORESORBABLE SHEET FTL POLYGANICS

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Unknown Other