BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRONE PATIENT POSITIONING KIT

    MDR report key: 11518820 · Received March 18, 2021

    Report

    Report Number
    1034876-2021-00001
    Event Type
    Injury
    Date Received
    March 18, 2021
    Date of Event
    February 17, 2021
    Report Date
    April 21, 2021
    Manufacturer
    CASSEMCO INC.
    Product Code
    CCX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION FINDING: THE LOT NUMBER REPORTED 1598904 WAS NOT FOUND FOR THIS PRODUCT. QUALITY SPECIALIST WAS UNABLE TO REVIEW MATERIAL INVENTORY. IT WAS DETERMINED THIS WAS A VENDOR ISSUE DUE TO A PROBABLE ISOLATED REACTION FROM THE PATIENT. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SENT TO CASSEMCO INC. THE SUPPLIER COMPLETED THE SCAR AND ATTACHED SAFETY DATA SHEET AND CERTIFICATE OF ANALYSIS AND COMPLIANCE RESULTS ON PRODUCT. THE CERTIFICATE OF ANALYSIS REPORTED SPECIFICATIONS WITHIN PASSING MEAN VALUES. (B)(4) UNITS OF FINISHED GOOD OF PRODUCT HAVE BEEN SOLD FROM FEBRUARY 2020 TO PRESENT, DURING THAT REVIEW PERIOD THIS IS THE ONLY COMPLAINT RECEIVED FOR THIS PRODUCT. THIS EQUATES TO A COMPLAINT RATIO OF (B)(4). ROOT CAUSE: UNABLE TO DETERMINE THE ROOT CAUSE TO THIS ISSUE DUE TO PROBABLE ISOLATED PATIENT RESPONSE TO FOAM MATERIAL. CORRECTION: NO CORRECTIVE ACTION WAS TAKEN TO THE PRODUCT. PREVENTION AND VERIFICATION: NONE, THIS IS ISOLATED INCIDENT. THE INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVALIABLE.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE CAN NOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS INCOMPLETE AT THIS TIME, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ADDITIONAL INFORMATION ONCE RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    PATIENT WAS PLACED IN THE PRONE POSITION USING M60-360 POSITIONING KIT. NURSE COULD NOT CONFIRM HOW OFTEN THE PATIENT WAS CHECKED FOR PRESSURE INJURY SYMPTOMS OR SKIN IRRITATIONS. PATIENT DID DEVELOP 2 SKIN IRRITATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411163 PRONE PATIENT POSITIONING KIT PATIENT POSITION SUPPORT CCX CASSEMCO INC. M60-360 1598904

    Patients

    Seq Age Sex Outcome Treatment
    1