BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN SURGICAL PATTIE

    MDR report key: 3790016 · Received May 5, 2014

    Report

    Report Number
    1226348-2014-11515
    Event Type
    Injury
    Date Received
    May 5, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    HBA
    PMA / PMN Number
    PK880402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN FOR EVALUATION; THEREFORE, THE EVALUATION COULD NOT BE PERFORMED AND THE ROOT CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. IN THE ABSENCE OF THE COMPLAINT SAMPLE, A COMPLAINTS RECORDS REVIEW WAS CONDUCTED. THE ORDERS (LOT 236533) WAS PRODUCED IN JUNE OF 2012. A REVIEW OF THE MANUFACTURING RECORDS DID NOT SHOW ANYTHING UNUSUAL REGARDING THE PRODUCTION OF THESE PATTIES. WE WILL CONTINUE TO MONITOR FOR TRENDS FOR THIS OR SIMILAR COMPLAINTS REGARDING THIS PRODUCT CODE. SHOULD THE PRODUCT BE MADE AVAILABLE FOR EVALUATION AT A LATER DATE WE WILL RE-OPEN THIS COMPLAINT AND EVALUATE THE PRODUCT. BASED ON THE INVESTIGATION THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED, ¿24-5411 SHOULD COME 10 EACH PER PACK. THIS PACK ONLY CONTAINED 9 EACH IN THE PACK.¿ (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268967 CODMAN SURGICAL PATTIE PADDIE, COTTONOID HBA CODMAN & SHURTLEFF 236533

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention