BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSWARMER INFANT TRANSPORT MATTRESS

    MDR report key: 23312357 · Received October 16, 2025

    Report

    Report Number
    1216677-2025-00043
    Event Type
    Injury
    Date Received
    October 16, 2025
    Date of Event
    October 1, 2025
    Report Date
    December 24, 2025
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    IMD
    UDI-DI
    00888937025767
    PMA / PMN Number
    K934631
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED: B4, D9, G3, G6, H2, H3, H4, H6, H11. DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS PURCHASED FROM PRISTECH PRODUCTS INC. ON 1/13/25 AND SOLD BETWEEN 1/17/25-8/29/25. MANUFACTURING RECORD REVIEW: DHR WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: IQC RECORD WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED 2 COMPLAINTS WITH SIMILAR REPORTED COMPLAINT CONDITIONS; HOWEVER, THEY COULD NOT BE CONFIRMED. PRODUCT RECEIPT: THE COMPLAINT PRODUCT 20421 LOT IL650 QTY. 1 WAS RETURNED ON 11/11/25. THE LOT NUMBER OF THE RETURNED PRODUCT MATCHED THE LOT NUMBER REPORTED. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED PHYSICAL DAMAGE. A RIP AT THE SEAM OF THE MATTRESS WAS FOUND. THE CONTENT OF THE MATTRESS WAS OPAQUE AND FIRM DUE TO THE OPENING. PHOTOS SUBMITTED BY THE CUSTOMER ALSO SHOW A PORTION OF THE MATTRESS TO BE OPAQUE, WHITE AND CRYSTALLINE WHICH IS CONSISTENT WITH THE RETURNED PRODUCT EVALUATION AND INDICATES THAT THE DAMAGE OCCURRED PRIOR TO RETURN SHIPPING BACK TO COOPERSURGICAL FOR EVALUATION. FUNCTIONAL EVALUATION: COMPLAINT PRODUCT WAS EVALUATED BY THE SUPPLIER. IT WAS FOUND TO BE DAMAGED, MOST LIKELY, BY THE CASE BEING DROPPED DURING TRANSIT. THIS CAUSED THE SEAM TO SPLIT, ACTIVATING THE SOLUTION. NOTE: THE MATTRESS WAS DAMAGED AND ACTIVATED, IT WOULD NOT FUNCTION PROPERLY WHEN THE CUSTOMER ATTEMPTED TO USE IT, WHICH CONFIRMS THE COMPLAINT. ANY RELEVENT CUSTOMER OR CLINICAL INFORMATION: THERE WAS NO RELEVANT CUSTOMER OR CLINICAL INFORMATION PROVIDED. ROOT CAUSE: WHILE NO DEFINITIVE ROOT CAUSE COULD BE RELIABLY DETERMINED, THE CAUSE MAY BE ATTRIBUTED TO DAMAGE INCURRED IN TRANSIT. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY.

    Additional Manufacturer Narrative · 0

    G2: FOREIGN: SWITZERLAND. DEVICE IS TO BE RETURNED BY THE DISTRIBUTOR. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ACTIVATION PLATE WAS ACTIVATED, BUT THE MATTRESS DID NOT GET WARM. THE WARMING MAT WAS USED IN THE INITIAL CARE OF PREMATURE BABIES, BUT IT DID NOT WARM UP DURING INITIAL CARE. AS A RESULT, THE PATIENT SUFFERED HYPOTHERMIA, WITH A BODY TEMPERATURE OF 34.2 DEGREES CELSIUS. ATTEMPTS HAVE BEEN CONDUCTED, BUT NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. 1216677-2025-00043 20421 TRANSWARMER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2098650 TRANSWARMER INFANT TRANSPORT MATTRESS REACTIVE-GEL HEATING PAD IMD COOPERSURGICAL, INC. 20421 IL650 00888937025767

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Other| R