BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUTIPLAST PLUS STERIL 10 X 24.8

    MDR report key: 19727317 · Received July 11, 2024

    Report

    Report Number
    8043484-2024-00068
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    July 2, 2024
    Report Date
    August 14, 2024
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: THIS COMPLAINT HAS BEEN REASSESSED BASED ON ADDITIONAL INFORMATION GATHERED BY THE MANUFACTURER. IT WAS DETERMINED THAT THIS EVENT DOES NOT FULFILL REPORTING REQUIREMENTS PER 21CFR803. THIS COMPLAINT/MDR REPORT HAS BEEN FOUND TO BE A DUPLICATE OF CASE (B)(4) (MDR REPORT 8043484-2024-00036). AS A RESULT, SMITH+NEPHEW NOW CONSIDERS CASE (B)(4) (MDR REPORT: 8043484-2024-00068) AS A NON VALID RECORD. ALL INVESTIGATION FINDINGS WILL BE COMMUNICATED THROUGH CASE (B)(4) IN DUE COURSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOUR (4) CUTIPLAST PLUS STERIL 10 X 24.8 PARTS WERE NOT WELDED SHUT AT THE END. THIS OF COURSE ELIMINATES THE STERILITY. AS THIS WAS NOTICED IN A NON-THERAPEUTIC ENVIRONMENT, THERE WAS NOT PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2444178 CUTIPLAST PLUS STERIL 10 X 24.8 DRESSING, WOUND, DRUG FRO SMITH & NEPHEW MEDICAL LTD. 2309B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown