BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEARL EDGE BELL CUP

    MDR report key: 20028946 · Received August 22, 2024

    Report

    Report Number
    1216677-2024-00044
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    October 12, 2023
    Report Date
    September 11, 2024
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HDB
    UDI-DI
    00888937003031
    PMA / PMN Number
    K011532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE LOCATION IS UNKNOWN. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED: B4, G3, G6, H2, H3, H4, H6, H11. DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 06-10-2020. MANUFACTURING RECORD REVIEW: DHR-10004 - 286151 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED NO REPORTED COMPLAINTS FOR THIS PART. PRODUCT RECEIPT: THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. ROOT CAUSE: ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IN NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA MEDWATCH REPORT THAT WAS FOUND IN THE MAUDE DATABASE: FAILED VACUUM EXTRACTION FOR DELIVERY OF NEWBORN RESULTING IN A LARGE HEMATOMA. ALLEGEDLY, THE COMPANY NOTIFIED THE ORGANIZATION THAT THE ITEM WAS BACK-ORDERED AND IT WAS ACCEPTABLE TO USE AN OUTDATED ITEM. 1216677-2024-00044 10004 PEARL CUP 2024-08-0000184.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126772 PEARL EDGE BELL CUP EXTRCTR CUP,PEARL EDG BEL W/FILTER HDB COOPERSURGICAL, INC. 10004 286151 00888937003031

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Male Other