BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BULK SURG STRIP 2 X 6

    MDR report key: 3790040 · Received May 5, 2014

    Report

    Report Number
    1226348-2014-11530
    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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT (B)(4). AN INITIAL IS BEING GENERATED TO SUBMIT AN MDR RECLASSIFYING THE INCIDENT AS A SERIOUS INJURY. UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE ROOT CAUSE IS LIKELY DUE TO OPERATOR ERROR. PER THE REQUIREMENTS OF THE SPECIFICATION THE OPERATOR IS REQUIRED TO COUNT THE AMOUNT OF SURGICAL STRIPS PRIOR TO SEALING THEM IN THE PACKAGE. THE MANUFACTURING DOCUMENTATION FOR LOTS 252120, 238243 WAS PULLED AND REVIEWED. THE REVIEW WAS CONDUCTED AND DID NOT YIELD ANY FINDINGS OUT OF THE ORDINARY RELATIVE TO THE PRODUCTION OF THIS LOT. THE COMPLAINT WAS REVIEWED WITH THE APPLICABLE OPERATORS. BASED ON THE INVESTIGATION THIS COMPLAINT IS CONSIDERED CLOSED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED ONLY 9 EACH OF THE COTTONOIDS IN THE PACK; SHOULD HAVE BEEN 10 EACH IN THE PACK. THE PRODUCT WAS FORWARDED TO (B)(4) FOR EVALUATION AND DHR REVIEW ON (B)(4) 2012. WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. PLEASE REFER TO COMPLAINT (B)(4). AN INITIAL IS BEING GENERATED TO SUBMIT AN MDR RECLASSIFYING THE INCIDENT AS A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268982 BULK SURG STRIP 2 X 6 COTTONOID, PADDIE HBA CODMAN & SHURTLEFF 252120,238243

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention