BEUDAMED
    FDA Adverse Event Death Summary report: N

    PELVIC SOFT BELT

    MDR report key: 15974023 · Received December 13, 2022

    Report

    Report Number
    2182318-2022-00140
    Event Type
    Death
    Date Received
    December 13, 2022
    Date of Event
    June 15, 2022
    Report Date
    November 16, 2022
    Manufacturer
    TIDI PRODUCTS
    Product Code
    FMQ
    UDI-DI
    10190676003447
    PMA / PMN Number
    K963414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED SOLELY ON THE INFORMATION PROVIDED BY THE PATIENT'S FAMILY MEMBER. PRODUCT IS NOT AVAILABLE FOR RETURN, THEREFORE, CONFIRMATION OF COMPLAINT AND THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE COMPLAINT DATABASE DID NOT REVEAL ANY ADVERSE EVENTS FOR THIS SKU. THEREFORE, IT APPEARS THIS COMPLAINT WAS AN ISOLATED EVENT. THE REPORTER INDICATED THAT HER MOTHER WAS UNDER HOSPITAL CARE AT (B)(6), WHERE A REPORTED UNWITNESSED FALL OCCURRED WHILE THE PATIENT WAS IN HER WHEELCHAIR ON (B)(6) 2022. SEVERAL DAYS AFTER THE FALL, THE PATIENT WAS REPORTED TO HAVE BLEEDING, AND WAS SEEN BY A DOCTOR WHO CONFIRMED THAT THE PATIENT HAD A CONCUSSION. THE PATIENT CONTINUED WITH HEAVY BLEEDING AND BECAME UNCONSCIOUS, WHICH THEN RESULTED IN HER PASSING ON (B)(6) 2022. THE REPORTER INDICATED THAT PRIOR TO THE INCIDENT, SHE SPENT EVERY DAY WITH HER MOTHER WHO HAD USED THE (B)(4). SHE HAS NO REPORTED ISSUES WITH THE INTEGRITY OF THE PRODUCT AND FELT IT WORKED PERFECT FOR HER MOTHER'S NEEDS. THE INSTRUCTIONS FOR USE (IFU) WAS REVIEWED AND WAS FOUND TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR SAFE AND EFFECTIVE USE OF THE DEVICE. THE INSTRUCTIONS FOR USE STATE DO NOT USE ON A PATIENT WHO IS OR BECOMES HIGHLY AGGRESSIVE, COMBATIVE, AGITATED, OR SUICIDAL. WARNING ALWAYS MONITOR PATIENTS PER FACILITY POLICY. IMPROPER APPLICATION OR USE OF ANY RESTRAINT MAY RESULT IN SERIOUS INJURY OR DEATH. TEST ZIPPERS OR HOOK-AND-LOOP FASTENERS BEFORE EACH USE. DISCARD DEVICE IF IT DOES NOT FASTEN SECURELY. AN ATTEMPT WAS MADE TO CONFIRM THE EVENT WITH THE HOSPITAL, AND DUE TO PATIENT PRIVACY, THEY WOULD NOT SHARE ANY INFORMATION TO SUPPORT THE INVESTIGATION. WITHOUT THE RETURN OF THE DEVICE, THE REPORTED ISSUE COULD NOT BE CONFIRMED. AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNING FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANT. MANUFACTURER REFERENCE FILE (B)(4). PRODUCT NOT RETURNED.

    Description of Event or Problem · 0

    CUSTOMER HAS ISSUED A COMPLAINT ON PRODUCT (B)(4). REPORTER STATES HER MOTHER WAS AT (B)(6). WHILE THERE AT THE HOSPITAL, THEY TOLD HER THAT HER MOTHER HAD AN UNWITNESSED FALL (WHICH SHE DIDNT BELIEVE TO BE TRUE). SHE SENT A HUBSPOT ASKING IF A PERSON COULD GET OUT OF THE (B)(4) BY SLIDING FORWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142540 PELVIC SOFT BELT RESTRAINT, PROTECTIVE FMQ TIDI PRODUCTS 4125C 10190676003447

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death