BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIMPROM POC TEST 10/BOX

    MDR report key: 11004859 · Received December 14, 2020

    Report

    Report Number
    1216677-2020-00300
    Event Type
    Malfunction
    Date Received
    December 14, 2020
    Date of Event
    October 24, 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
    MO, 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 MANUFACTURING RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. INCOMING INSPECTION REVIEW IQC RECORD-(B)(4) WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. SERVICE HISTORY RECORD SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DID NOT SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. 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. *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). PATIENT 1= ACTIM PROM COLLECTED ON (B)(6) 2020 AT 2125 POSITIVE RESULT REPORTED AT 2206. DR. PERFORMED ARTIFICIAL RUPTURE OF MEMBRANES DUE TO INTACT AMNIOTIC SAC WITH MECONIUM PRESENT, THAT WASN'T PRESENT PRIOR TO ARTIFICIAL 1216677-2020-00300 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). PATIENT 1= ACTIM PROM COLLECTED ON (B)(6) 2020 AT 2125 POSITIVE RESULT REPORTED AT 2206. DR. PERFORMED ARTIFICIAL RUPTURE OF MEMBRANES DUE TO INTACT AMNIOTIC SAC WITH MECONIUM PRESENT, THAT WASN'T PRESENT PRIOR TO ARTIFICIAL. ACTIMPROM POC TEST 10 BOX 30831ETUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467441 ACTIMPROM POC TEST 10/BOX ACTIMPROM POC TEST 10/BOX OAM COOPERSURGICAL INC. 30800ETUS -

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other