BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN LEUKOSTRIP

    MDR report key: 10405021 · Received August 13, 2020

    Report

    Report Number
    8043484-2020-02489
    Event Type
    Injury
    Date Received
    August 13, 2020
    Report Date
    March 12, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    MZR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE USED IN TREATMENT HAS NOT BEEN RETURNED FOR EVALUATION, WITH NO ADDITIONAL INFORMATION PROVIDED WE HAVE NOT BEEN ABLE TO ESTABLISH A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT OR DETERMINE A ROOT CAUSE ON THIS OCCASION. MEDICAL REVIEW CONCLUDED, THE ROOT CAUSE OF THE REPORTED INFECTION AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE COULD NOT BE CONFIRMED NOR CONCLUDED; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. PROBABLE CAUSE IS INHERENT RISK OF INFECTION FROM PROCEDURE. INDICATIONS; FOR PRIMARY AND SECONDARY CLOSURE OF SKIN WOUNDS. USED IN THE FIXATION OF SKIN GRAFTS. THE INSTRUCTIONS FOR USE PROVIDE COMPREHENSIVE INSTRUCTIONS OF THE OPERATION, USE AND LIMITATIONS OF THE DEVICE. THE ASSOCIATED RISK FILES CONTAIN DETAILS RELATING TO HARM. HOWEVER, THE CLINICAL REVIEW HAS NOT ESTABLISHED A CAUSAL LINK. ADDITIONAL RMR IS NOT REQUIRED. NO BATCH LOT NUMBER HAS BEEN PROVIDED RENDERING A REVIEW OF THE DEVICE HISTORY NOT POSSIBLE. A COMPLAINT HISTORY REVIEW FOUND OTHER RELATED FAILURES. THIS INVESTIGATION IS NOW COMPLETE WITH NO FURTHER ACTION DEEMED NECESSARY. SMITH + NEPHEW WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.

    Description of Event or Problem · 1

    IT THE STUDY "DOES TAPING TORSO SCARS FOLLOWING DERMATOLOGIC SURGERY IMPROVE SCAR APPEARANCE?" THERE WERE A TOTAL OF 195 PATIENTS USING LEUKOSTRIP AND OR MELOLIN & OPSITE DRESSINGS. CONTROL GROUP DID NOT USE LEUKOSTRIP BUT INTERVENTIONED GROUP DID. IT WAS REPORTED THAT A PATIENT DEVELOPED INFECTION. IT IS UNKNOWN WHAT KIND OF TREATMENT WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866220 UNKN LEUKOSTRIP TOPICAL APPROXIMATION SYSTEM MZR SMITH & NEPHEW MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R