BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREND DYNAWRAP

    MDR report key: 20142677 · Received September 5, 2024

    Report

    Report Number
    3011491271-2024-00001
    Event Type
    Injury
    Date Received
    September 5, 2024
    Date of Event
    March 1, 2024
    Report Date
    March 15, 2024
    Manufacturer
    CHENGDU CRYO-PUSH MEDICAL TECHNOLOGY CO.,LTD
    Product Code
    IRP
    PMA / PMN Number
    K222669
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT HAS BEEN RETURNED FOR INVESTIGATION AND IT IS NOT EXPECTED THAT A PRODUCT WILL BE AVAILABLE FOR EVALUATION. BASED ON THIS, IT WILL NOT BE POSSIBLE TO ESTABLISH IF THERE WAS A MALFUNCTION INVOLVED IN THIS ALLEGED INCIDENT. WE INVESTIGATED THIS SITUATION INTERNALLY WITH THE IMPORTER. THE MDR REPORT (NO. MW5152912) SAID "I ORDERED TREND DYNAWRAP IN JANUARY', SO WE REVIEWED SALES RECORD AT THAT TIME, ONLY 3 WRAPS WERE SHIPPED TO ONE CUSTOMER. WE CONTACTED THIS CUSTOMER TO SEE IF THERE WAS AN ISSUE WITH THE USAGE. HE NOTIFIED US THAT HE ONLY HAD PUT ONE WRAP ON A PATIENT AND TWO WERE STILL IN HIS WAREHOUSE. HE THEN CHECKED WITH THE PATIENT THAT HAD THE ONLY WRAP AND THE PATIENT SAID THAT THE WRAP WAS DOING GREAT AND THERE WAS NO ISSUE. CONTACT RECORDS WILL BE PROVIDED IN SUPPLEMENTAL REPORT. WE CONCLUDED THAT THIS INCIDENT WAS EITHER A FALSE REPORT OR A PRODUCT THAT WAS NOT SUPPLIED BY US.

    Description of Event or Problem · 0

    AN INCIDENT REPORT WAS LEARNED FROM MEDWATCH, IT WAS DESCRIBED AS : I ORDERED TREND DYNAWRAP IN (B)(6). I THINK IT IS SAFETY AIR PUMP AS THEIR WEBSITE SAYS COMPLETE CERTIFICATES FDA 510K. THE PUMP'S BIG PRESSURE MADE WRAP EXPLODED FIRST AND THEN THE PUMP EXPLODED. AIR PUMP DEBRIS HIT MY FACE AND BLOOD. I FIND TREND MEDICAL LLC NO FDA 510K.DYNAWRAP IS A BAD PUMP WHICH THREAD AMERICAN'S LIFE.FOLLOWING IS DYNAWRAP ON TREND MEDICAL LLC WEBSITE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833848 TREND DYNAWRAP COLD COMPRESSION DEVICE IRP CHENGDU CRYO-PUSH MEDICAL TECHNOLOGY CO.,LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening