BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FETAL PILLOW, BOX OF 6

    MDR report key: 15157230 · Received August 3, 2022

    Report

    Report Number
    1216677-2022-00217
    Event Type
    Injury
    Date Received
    August 3, 2022
    Date of Event
    July 20, 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
    TX, 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: IQC RECORD-22-02-02-028 AND IQC RECORD-22-03-21-003 WERE 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: 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

    DR (B)(6) (GYN) STATED THAT HE UTILIZED FETAL PILLOW WITH A JEHOVAH'S WITNESS PATIENT WHO HAD A LEFT SIDE UTERINE EXTENSION WITH BLOOD LOSS RESULTING IN A HYSTERECTOMY AND MOM WENT TO ICU AND BABY WENT TO NICU. PATIENT SUFFERED LARGE UTERINE TEAR WHO ENDED UP IN THE ICU AND HER BABY IN THE NICU. 1216677-2022-00217 FETAL PILLOW BOX OF 6 FP-010, (B)(4).

    Description of Event or Problem · 0

    DR (B)(6) (GYN) STATED THAT HE UTILIZED FETAL PILLOW WITH A JEHOVAH'S WITNESS PATIENT WHO HAD A LEFT SIDE UTERINE EXTENSION WITH BLOOD LOSS RESULTING IN A HYSTERECTOMY AND MOM WENT TO ICU AND BABY WENT TO NICU. PATIENT SUFFERED LARGE UTERINE TEAR WHO ENDED UP IN THE ICU AND HER BABY IN THE NICU. 1216677-2022-00217 FETAL PILLOW BOX OF 6 FP-010 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583515 FETAL PILLOW, BOX OF 6 FETAL PILLOW PWB COOPERSURGICAL INC. FP-010 21336

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| H| R