BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITYONE MUSHROOM CUP

    MDR report key: 8219308 · Received January 4, 2019

    Report

    Report Number
    1216677-2018-00097
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Date of Event
    December 13, 2018
    Report Date
    February 22, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HDB
    UDI-DI
    00888937003123
    PMA / PMN Number
    K890307
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION. INITIATED MANUFACTURER'S INVESTIGATION. REVIEW DHR. *ANALYSIS AND FINDINGS. THE RETURNED SAMPLE WAS NOT AVAILABLE AT THE TIME OF THIS INVESTIGATION (9/13/19), SHOULD THE SAMPLE BE LOCATED AND MADE AVAILABLE FOR COMPLAINT INVESTIGATION ANALYSIS, THE COMPLAINT MAY BE REOPENED AND ADDRESSED AS NEEDED. INVENTORY REVIEW INDICATED THAT THE LOT WAS FULLY DEPLETED AND NO LONGER AVAILABLE FOR VERIFICATION. A REVIEW OF THE TWO-YEAR PRODUCT COMPLAINT HISTORY INDICATED ONE OTHER SIMILAR REPORTED EVENT. A REVIEW OF THE CSI LOT (233891) DHR INDICATED THE M-CUP SUBASSEMBLY LOT TO HAVE BEEN LM234079. DHR REVIEW DID NOT INDICATE ANY ABNORMALITIES. SUPPLIER SPC DATA INDICATED THE PULL FORCE ON THE CUP SUBASSEMBLY TO HAVE BEEN WELL ABOVE THE 41LBS MINIMUM. PAST COMPLAINT HISTORY SIMILAR IN NATURE HAVE INDICATED THAT IT'S NOT A DEVICE FAILURE, AS MUCH AS THE DEVICE FAILURE MAY HAVE BEEN THE RESULT OF USING THE DEVICE CONTRARY TO INDICATED USE INSTRUCTIONS. BASED ON THE INFORMATION AVAILABLE, NO FURTHER ACTION IS REQUIRED. IT SHOULD BE NOTED THAT EACH COMPLETED VAD DEVICE IS INDIVIDUALLY ACCESSED FOR VISUAL AND FUNCTIONAL ACCEPTANCE BEFORE BEING PACKAGED, STERILIZED AND RELEASED TO FG WAREHOUSE. CORRECTION AND/OR CORRECTIVE ACTION. CORRECTIVE ACTIVE ACTION IS NOT WARRANTED AT THIS TIME AS THE AFFECTED DEVICE WAS NOT AVAILABLE FOR INVESTIGATIVE ANALYSIS. ALL PAST COMPLAINT TESTING HAS NOT BEEN ABLE TO REPLICATE THE TYPE OF REPORTED EVENT WHEN USED IN ACCORDANCE WITH THE IFU INSTRUCTION GUIDELINES. PER BSR-QAR-026 THIS COMPLAINT WILL BE MONITORED FOR TRENDING IN THAT NO INJURY WAS REPORTED TO END USER, OR PATIENT. *WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    THE MUSHROOM CUP WAS DAMAGED DURING A DELIVERY. 1216677-2018-00097-1 MITYONE MUSHROOM CUP 10067 (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    THE MUSHROOM CUP FAILED DURING A DELIVERY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9368 MITYONE MUSHROOM CUP MITYONE MUSHROOM CUP HDB COOPERSURGICAL, INC. 10067 233891 00888937003123

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other