BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACTION BOOTS, PAIR

    MDR report key: 13023869 · Received December 17, 2021

    Report

    Report Number
    8010652-2021-00034
    Event Type
    Malfunction
    Date Received
    December 17, 2021
    Date of Event
    October 14, 2021
    Report Date
    December 17, 2021
    Manufacturer
    HOLGER ULLRICH
    Product Code
    BWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH STRAP RIPPED AT TRACTION BOOTS. IT WAS STATED THAT STRIP AT ONE OF THE TRACTION BOOTS RIPPED DURING THE FIRST USE OF THE TRACTION BOOT. WE DECIDED TO REPORT THE ISSUE DUE TO MAJOR DELAY OF THE SURGERY (ABOUT 30 MINUTES). BASED ON INFORMATION PROVIDED BY GETINGE TECHNICIAN, THE TRACTION BOOTS WERE REPLACED UNDER WARRANTY. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE TRACTION BOOTS DID NOT MEET THEIR SPECIFICATION DUE TO THE STRAP HAVING RIPPED. PROVIDED INFORMATION INDICATES THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. WHEN THE EVENT OCCURRED THE TRACTION BOOTS WERE DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. REVIEW OF RECEIVED CUSTOMER PRODUCT COMPLAINTS RELATED TO INVESTIGATED ISSUES, REVEALED THAT THERE WERE NO INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR MALFUNCTIONS OCCURRED. ACCORDING TO THE REVIEW OF THE COMPLAINTS DATABASE FROM LAST 5 YEARS LIKELIHOOD OF SUCH EVENT IS RARE AND UP TO TWO EVENTS PER YEAR. DUE TO THE FACT THAT CUSTOMER DID NOT PROVIDE AFFECTED TRACTION BOOTS FOR FURTHER INVESTIGATION (THE TRACTION BOOTS WERE DESTROYED BY THE CUSTOMER) WE CAN ONLY ASSUME PROBABLE ROOT CAUSE FOR THIS ISSUE. WE ASSUME THAT THIS ISSUE OCCURRED DUE TO A SUPPLIER FAILURE WHICH IS SIMILAR TO PREVIOUSLY REPORTED COMPLAINTS. WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY ACTION AT THIS TIME. THE CORRECTION OF H8 USAGE OF THE DEVICE FIELD DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS H8 USAGE OF THE DEVICE. UNKNOWN. CORRECTED H8 USAGE OF THE DEVICE. INITIAL USE.

    Additional Manufacturer Narrative · 0

    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 MEDWACHT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO US. A STRIP AT ONE OF THE TRACTION BOOTS RIPPED DURING THE FIRST USE OF THE TRACTION BOOT. THE CLINIC CONFIRMED THAT THE PATIENT WAS NOT INJURED. THIS INFORMATION WAS RECEIVED ON (B)(6). ON (B)(6) WE RECEIVED FURTHER INFORMATION FROM THE CLINIC. THE SURGERY WAS DELAYED BY 30 MINUTES DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928037 TRACTION BOOTS, PAIR TABLE AND ATTACHMENTS, OPERATING-ROOM BWN HOLGER ULLRICH 10018800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other