BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEAD POSITIONER,SURGICAL, 24/C, SOFT TOUCH HEAD PILLOW

    MDR report key: 19931681 · Received August 7, 2024

    Report

    Report Number
    1034876-2023-00001
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    April 21, 2023
    Report Date
    June 14, 2023
    Manufacturer
    CASSEMCO INC.
    Product Code
    CCX
    UDI-DI
    00749756599658
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED ON 4/21/2023, THAT THERE WAS SOME ABRASION AND SKIN TEARING ON PATIENTS FACE AFTER USE OF A SURGICAL HEAD POSITIONER. THE HEAD POSITIONER IS NOT AVAILABLE FOR RETURN. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE SENT TO CASSEMCO INC. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT ONCE MORE INFORMATION IS CONCLUDED FROM THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE FOAM SUPPLIER CASSEMCO. ROOT CAUSE: WAS DETERMINED TO BE UNKNOWN BY THE SUPPLIER AS FOUND ALL INVENTORY WAS WITHIN CONFORMANCE STANDARDS. CORRECTIVE AND PREVENTATIVE ACTIONS: CASSEMCO DID NOT TAKE ANY CORRECTIVE OR PREVENTATIVE ACTIONS AS NO PROBLEM WAS FOUND. BECAUSE NO LOT NUMBER WAS GIVEN, DEROYAL INDUSTRIES REVIEWED THE LAST THREE LOTS SENT TO COMPLAINT REPORTING CUSTOMER, AND NO ISSUES WERE FOUND. DEROYAL ALSO REVIEWED INVENTORY AND FOUND IT TO BE ACCEPTABLE. NO ENGINEERING CHANGES OR CORRECTIVE ACTION OR PREVENTATIVE ACTIONS WERE FOUND TO BE RELATED TO THIS ISSUE. A COMPLAINT TO SALES RATIO WAS CALCULATED BETWEEN APRIL 2021 TO MAY 2023 SOLD (B)(4) UNITS OF THE FINISHED GOOD ((B)(4) EACHES) AND DURING THAT SAME PERIOD RECEIVED ONE COMPLAINT. THIS CREATES A RATIO OF (B)(4). DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS SURROUNDING THIS ITEM AND ISSUE. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    SOME ABRASION AND SKIN TEARING ON PATIENTS FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546223 HEAD POSITIONER,SURGICAL, 24/C, SOFT TOUCH HEAD PILLOW SUPPORT, PATIENT POSITION CCX CASSEMCO INC. M9504 00749756599658

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other