BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACTION BOOTS, PAIR

    MDR report key: 11861401 · Received May 21, 2021

    Report

    Report Number
    8010652-2021-00020
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    May 6, 2021
    Report Date
    August 26, 2021
    Manufacturer
    HOLGER ULLRICH
    Product Code
    BWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED TRACTION BOOT WAS RETURNED TO THE MANUFACTURING SITE FOR FURTHER INVESTIGATION. THE RESULT OF THIS INVESTIGATION WAS THAT A MANUFACTURING FAILURE AT OUR SUPPLIER IS THE ROOT CAUSE. TO LITTLE FAT WAS USED DURING THE TANNING PROCESS. THIS CAUSED CRACKS IN THE LEATHER. THE TANNING PROCESS AT THE SUPPLIER WAS CHANGED. MORE FAT IS USED IN THE TANNING PROCESS. GETINGE-MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    THE CLINIC CONFIRMED THAT NO INJURY OF THE PATIENT HAS OCCURRED. MANUFACTURER REFERENCE (B)(4).

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT THE INVESTIGATION IS STILL ONGOING. WHEN THE INVESTIGATION IS COMPLETE THE REPORT WILL BE UPDATED AND A FOLLOW UP MEDWATCH WILL BE SUBMITTED. THE INITIAL REPORTERS PHONE NUMBER IS: (B)(6).

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO US. A LEATHER STRAP OF THE TRACTION BOOT RIPPED DURING SURGERY. THAT IS WHY THE PATIENTS FOOT SLIPPED OUT OF THE TRACTION BOOT AND FELL DOWN. THE USER STATED THAT A JOINT OF THE PATIENT "SNAPPED BACK". NO INJURY OF THE PATIENT WAS REPORTED TO US. MANUFACTURER REFERENCE#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758152 TRACTION BOOTS, PAIR TABLE AND ATTACHMENTS, OPERATING-ROOM BWN HOLGER ULLRICH 10018800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other