BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAUZE SPONGES X-RAY DETECTABLE

    MDR report key: 7026379 · Received November 13, 2017

    Report

    Report Number
    2027062-2017-00001
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    August 10, 2017
    Report Date
    September 20, 2017
    Manufacturer
    BIOSEAL
    Product Code
    GDY
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    MW5071793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING SUPPLIER RESPONSE IF THERE ARE OTHER COMPLAINTS FROM THE FIELD. UPDATE: AMD RITMED REPORTED THAT ACTIONS, SEE INVESTIGATION DETAILS, HAVE BEEN TAKEN TO PREVENT LINT DURING THE MANUFACTURING PROCESS. NO INDICATION OF OTHER COMPLAINTS IN THE FIELD. (B)(4).

    Additional Manufacturer Narrative · 1

    AWAITING SUPPLIER RESPONSE IF THERE ARE OTHER COMPLAINTS FROM THE FIELD.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO BIOSEAL BY MW5071793: WE ARE HAVING DIFFICULTY WITH THE SURGICAL GAUZE BREAKING OFF TINY PIECES INTO THE SURGICAL FIELD, WE ARE NOT SURE IF OTHER DEPARTMENTS ARE HAVING THIS ISSUE TOO. BUT ALSO COPIED THE OTHER (B)(6) PROVIDERS TO SEE IF THEY'RE HAVING THE SAME PROBLEM WITH THE GAUZE. WE ARE CONCERNED AS THIS CAN CERTAINLY INCREASE THE RISK OF POST-OPERATIVE INFECTION. WE ARE TRYING TO REMOVE ALL OF THE TINY GAUZE MATERIAL FROM THE SURGICAL FIELD PRIOR TO CLOSURE AND WE ARE ALSO TRYING TO RELY ON Q-TIPS INSTEAD OF USING THE SURGICAL GAUZE, BUT I REALLY THINK WE MAY HAVE GOTTEN A DEFECTIVE GAUZE. NO REPORTER INFORMATION WAS INCLUDED WITH MW5071793; THEREFORE, THE REPORTING FACILITY COULD NOT BE CONTACTED. 11/13/2017:(B)(6) REQUESTED AN RMA FOR THE RETURN OF TWO BOXES OF UNUSED 7120/50 ON 11/13/2017 FOR GAUZE FLAKYING OFF. NO FURTHER INFORMATION COULD BE RECEIVED BUT IT WAS CONFIRMED ON 12/6/2017 THAT THE INCIDENT REPORTED WAS BELIEVED TO BE THE SAME.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO BIOSEAL BY MW5071793: WE ARE HAVING DIFFICULTY WITH THE SURGICAL GAUZE BREAKING OFF TINY PIECES INTO THE SURGICAL FIELD, WE ARE NOT SURE IF OTHER DEPARTMENTS ARE HAVING THIS ISSUE TOO. BUT ALSO COPIED THE OTHER (B)(6) PROVIDERS TO SEE IF THEY'RE HAVING THE SAME PROBLEM WITH THE GAUZE. WE ARE CONCERNED AS THIS CAN CERTAINLY INCREASE THE RISK OF POST-OPERATIVE INFECTION. WE ARE TRYING TO REMOVE ALL OF THE TINY GAUZE MATERIAL FROM THE SURGICAL FIELD PRIOR TO CLOSURE AND WE ARE ALSO TRYING TO RELY ON Q-TIPS INSTEAD OF USING THE SURGICAL GAUZE, BUT I REALLY THINK WE MAY HAVE GOTTEN A DEFECTIVE GAUZE. NO REPORTER INFORMATION WAS INCLUDED WITH MW5071793; THEREFORE, THE REPORTING FACILITY COULD NOT BE CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803252 GAUZE SPONGES X-RAY DETECTABLE GDY BIOSEAL 7120/50 1243

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention