BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNIFE 3722110 SICKLE

    MDR report key: 15324608 · Received August 30, 2022

    Report

    Report Number
    3003249645-2022-00042
    Event Type
    Injury
    Date Received
    August 30, 2022
    Date of Event
    August 5, 2022
    Report Date
    December 6, 2022
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    JYO
    UDI-DI
    10381780082217
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE SUSPECTED SICKLE KNIFE (3722110) WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES RELATED TO THE REPORTED COMPLAINT WERE FOUND. A DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THIS COMPLAINT MAY BE THE RESULT OF THE PRODUCT NOT BEING PACKAGED IN A PROTECTIVE PLASTIC CASE. THE PRODUCT DRAWING DID NOT SPECIFY THAT THE PRODUCT SHOULD BE PACKAGED IN A PLASTIC CASE UNTIL JULY-2019 AND THIS REPORTED PRODUCT LOT INDICATES MANUFACTURE DATE OF JANUARY 2019. INSPECTION OF PRE-2020 LOTS WAS INITIATED FOR THIS ISSUE AT THE LOCAL DISTRIBUTION CENTER AND WERE DISCARDED.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT THE CUSTOMER WAS CUT BY THE SICKLE KNIFE (3722110) WHEN OPENING THE BOX. IT WAS REPORTED THE INSTRUMENT WAS NOT IN ANY PACKAGING; THERE WAS NO PROTECTIVE COVERING OR BUBBLE WRAP. THERE WAS NO PATIENT INVOLVEMENT; THUS, NO PATIENT INJURY OR SURGICAL DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301058 KNIFE 3722110 SICKLE PFM11 JYO INTEGRA MICROFRANCE S.A.S. 3722110 AZ1901 10381780082217

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown