BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA MILTEX

    MDR report key: 17583639 · Received August 21, 2023

    Report

    Report Number
    17583639
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    June 28, 2023
    Report Date
    June 28, 2023
    Manufacturer
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION
    Product Code
    FZS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE INTEGRA MILTEX DISPOSABLE DERMAL CURETTE 4MM HAS BEEN REPORTED BY OUR WOUND PROVIDERS AT BOTH FACILITIES AS BEING SPORADICALLY DULL/NOT CONTAINING A SHARP EDGE. PRODUCT WITHIN THE SAME LOT CONTAINS BOTH PRODUCTS WITH THE EXPECTED STANDARD WHILE OTHERS DO NOT. THE PROVIDERS REPORT THAT THEY HAVE HAD AT LEAST (7) CURETTES WITH THIS DEFECT, DISPOSING OF A FEW WHEN THIS INITIALLY OCCURRED. WE HAVE RETAINED A FEW OF THESE INSTRUMENTS HOWEVER ALL HAVE HAD PATIENT CONTACT AND COULD NOT BE CLEANED COMPLETELY TO REMOVE CONTAMINATION. AFFECTED PRODUCT LOT: #220814, EXPIRATION 8/1/2027. LOT: #220912, EXPIRATION 9/1/2027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578568 INTEGRA MILTEX CURETTE, SURGICAL, GENERAL USE FZS INTEGRA LIFESCIENCES PRODUCTION CORPORATION 33-54 220814

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown