BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIMPROM POC TEST 10/BOX

    MDR report key: 11120244 · Received January 5, 2021

    Report

    Report Number
    1216677-2020-00310
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Date of Event
    October 12, 2020
    Report Date
    November 18, 2022
    Manufacturer
    COOPERSURGICAL INC.
    Product Code
    OAM
    PMA / PMN Number
    K123986
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: X-NO SAMPLE RETURNED: *ANALYSIS AND FINDINGS : DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS PURCHASED FROM ACTIM OY. MANUFACTURING RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. INCOMING INSPECTION REVIEW: A REVIEW OF THE INCOMING INSPECTION RECORD COULD NOT BE PERFORMED AS THE RECORD COULD NOT BE LOCATED AT THE TIME OF THIS INVESTIGATION. IF THE INCOMING INSPECTION RECORD SHOULD BE LOCATED GOING FORWARD, IT WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. SERVICE HISTORY RECORD: SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DIDN'T SHOW SIMILAR REPORTED COMPLAINT CONDITIONS OF A FALSE NEGATIVE OF GROSSLY RUPTURED MEMBRANES. 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 NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. *CORRECTION AND/OR CORRECTIVE ACTION : COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NO FURTHER TRAINING REQUIRED AT THIS TIME. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    E-COMPLAINT-(B)(4). THEY GOT A FALSE NEGATIVE OF GROSSLY RUPTURED MEMBRANES. 1216677-2020-00310 ACTIMPROM POC TEST 10/BOX 30831ETUS E-COMPLAINT-(B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    (B)(4) THEY GOT A (B)(6) OF GROSSLY RUPTURED MEMBRANES. ACTIMPROM CARTON WITH CSI 30831ETUS-BOX (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17222 ACTIMPROM POC TEST 10/BOX ACTIMPROM POC TEST 10/BOX OAM COOPERSURGICAL INC. 30831ETUS -

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other