BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALICOIL - PK

    MDR report key: 2890298 · Received December 29, 2012

    Report

    Report Number
    1219602-2012-00371
    Event Type
    Malfunction
    Date Received
    December 29, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 30, 2012
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE UNOPENED AND UNUSED DEVICE WAS RETURNED FOR EVALUATION. THE USED DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE THE MANUFACTURER WAS UNABLE TO PERFORM ANY FUNCTIONAL TESTING. A REVIEW OF THE STERILITY RECORDS WERE PERFORMED FOR THE REPORTED PART AND LOT NUMBER WHICH CONFIRMED THAT THE LISTED LOT OF PRODUCT WAS STERILIZED PER STANDARD PROCESS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A ROTATOR CUFF REPAIR ON (B)(6) 2012, WHEREIN DR. USED A 5.5 MM HEALICOIL PK AND AN ARTHREX IMPLANT. SOMETIME POST-OPERATIVE, THE PATIENT DEVELOPED AN INFECTION AT THE SURGICAL SITE. A SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2012. AN INCISION AND DRAINAGE OF THE SURGICAL SITE WITH IRRIGATION AND DEBRIDEMENT WAS PERFORMED. THE PATIENT WAS ALSO TREATED WITH ANTIBIOTICS. IT WAS REPORTED THAT THE HARDWARE WAS REMOVED FROM THE PATIENT. THE CUFF REPAIR WAS CONVERTED FROM 'L' SHAPE TEAR TO SMALL FULL THICKNESS ANTERIOR TEAR. NO FURTHER INFORMATION REGARDING THE METHOD OF REPAIR OR THE MATERIALS/IMPLANTS USED IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALICOIL - PK HEALICOIL SA PK 5.5MM W/2 UB-BL MBI MANSFIELD MANUFACTURING SITE 72203379 50427511

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention