BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL PATTIE, 1/2 X 1/2

    MDR report key: 5216980 · Received November 11, 2015

    Report

    Report Number
    1226348-2015-10658
    Event Type
    Injury
    Date Received
    November 11, 2015
    Date of Event
    August 1, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBN
    PMA / PMN Number
    PK880402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿RADIOGRAPHIC DETECTABILITY OF RETAINED NEUROPATHIES IN A CADAVER MODEL¿ (2015) 84, 2:405-411, HTTP://DX.DOI.ORG/10.1016/J.WNEU.2015.03.032, IT WAS REPORTED THAT CODMAN NEURO PATTIES IN SIZES ¼ X ¼ AND ½ X ½ HAD IN ADEQUATE RADIOPACITY. COUNTS ARE THE COMMONEST METHOD USED TO ENSURE THAT ALL SPONGES AND NEUROPATHIES ARE REMOVED FROM A SURGICAL SITE BEFORE CLOSURE. WHEN THE COUNT IS NOT RECONCILED, PLAIN RADIOGRAPHS OF THE OPERATIVE SITE ARE TAKEN TO DETERMINE WHETHER THE MISSING PATTY HAS BEEN LEFT IN THE WOUND. THE PURPOSE OF THIS STUDY WAS TO DESCRIBE THE DETECTABILITY OF COMMONLY USED NEUROPATHIES IN THE CLINICAL SETTING USING DIGITAL TECHNOLOGIES. THREE SURGICAL SITES WERE CHOSEN: THE ANTERIOR CRANIAL FOSSA, THE POSTERIOR CRANIAL FOSSA, AND THE THORACOLUMBAR EXTRADURAL SPACE. EACH OPERATIVE SITE WAS DRAPED IN THE USUAL MANNER WITH DRAPES BEING SECURED WITH SURGICAL STAPLES TO SIMULATE TYPICAL INTRAOPERATIVE ARTIFACTS. CRANIOTOMIES AND LAMINECTOMIES WERE PERFORMED TO ALLOW ACCESS FOR THE PLACEMENT OF THE NEUROPATHIES. NEUROPATHIES (THE FOUR PRODUCTS TESTED IN OUR STUDY WERE, CODMAN (RAYNHAM, MA) SURGICAL PATTIES: 80-1399 1/4 _ 1/4 IN [64 _ 64 CM]; 80-1400 1/2 _ 1/2 IN [1.27 _ 1.27 CM]; 80-1406 1/2 _ 2 IN [1.27 _ 5.06 CM]; 80-1408 1 _ 3 IN [2.54 _ 7.62 CM]) WERE IMPLANTED IN RANDOMIZED COMBINATIONS INTO EACH SURGICAL SITE AND POSITIONED IN CLINICALLY RELEVANT SUBREGIONS AS DESCRIBED. UNDER SIMULATED OPERATING ROOM CONDITIONS AND USING CURRENTLY AVAILABLE NEUROPATHIES AND PLAIN RADIOGRAPH IMAGING TECHNOLOGY, SMALL 1/4-IN AND 1/2-IN NEUROPATHIES ARE POORLY VISIBLE/DETECTABLE ON DIGITAL IMAGES. AT THE TIME OF COMPLAINT ENTRY THERE ARE NO KNOWN LOT NUMBERS AND THE DEVICES ARE NOT AVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749311 SURGICAL PATTIE, 1/2 X 1/2 SURGICAL SPONGE HBN CODMAN & SHURTLEFF, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention