BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FETAL PILLOW, BOX OF 6

    MDR report key: 15562568 · Received October 7, 2022

    Report

    Report Number
    1216677-2022-00272
    Event Type
    Injury
    Date Received
    October 7, 2022
    Date of Event
    September 10, 2022
    Report Date
    February 3, 2023
    Manufacturer
    COOPERSURGICAL INC.
    Product Code
    PWB
    PMA / PMN Number
    DEN150053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION : X-NO SAMPLE RETURNED . ANALYSIS AND FINDINGS : DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS PURCHASED FROM VITALCARE TRADING LIMITED. MANUFACTURING RECORD REVIEW: MANUFACTURING RECORD REVIEW IS NOT APPLICABLE FOR THIS PRODUCT. INCOMING INSPECTION REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED BECAUSE THE LOT/SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, IT SHOULD BE NOTED AT THE TIME OF MANUFACTURE RECORDS FROM EACH LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL COOPERSURGICAL QUALITY RELEASE SPECIFICATIONS. SHOULD THE COMPLAINT PRODUCT LOT/SERIAL NUMBER BE PROVIDED GOING FORWARD, THE DEVICE HISTORY RECORD 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 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 : 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

    WHEN SPEAKING WITH THE PHYSICIAN ABOUT FETAL PILLOW HE STATED HE ONLY USED FETAL PILLOW ONCE WITH A SEVERELY IMPACTED HEAD. THE BABY DEVELOPED A SUBDURAL HEMATOMA. HE SAID IT WAS LIKELY NOT RELATED TO THE FETAL PILLOW BUT WANTED TO KNOW IF IT IS POSSIBLE IF THE USE OF IT INCREASED THE RISK. FETAL PILLOW BOX OF 6 FP-010, (B)(4).

    Description of Event or Problem · 0

    WHEN SPEAKING WITH THE PHYSICIAN ABOUT FETAL PILLOW HE STATED HE ONLY USED FETAL PILLOW ONCE WITH A SEVERELY IMPACTED HEAD. THE BABY DEVELOPED A SUBDURAL HEMATOMA. HE SAID IT WAS LIKELY NOT RELATED TO THE FETAL PILLOW BUT WANTED TO KNOW IF IT IS POSSIBLE IF THE USE OF IT INCREASED THE RISK. 1216677-2022-00272 FETAL PILLOW BOX OF 6 FP-010 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2080120 FETAL PILLOW, BOX OF 6 FETAL PILLOW PWB COOPERSURGICAL INC. FP-010 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| O| R