BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMBAR DECOMPRESSION (ISLD70)

    MDR report key: 15183599 · Received August 8, 2022

    Report

    Report Number
    3007069947-2022-00002
    Event Type
    Injury
    Date Received
    August 8, 2022
    Date of Event
    June 6, 2022
    Report Date
    September 5, 2022
    Manufacturer
    AMERICAN CONTRACT SYSTEMS
    Product Code
    OJG
    UDI-DI
    09501101020016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT HAS NOT BEEN RECEIVED BUT A SAMPLE IS ANTICIPATED FROM THE REPORTER FOR EVALUATION. PATIENT 2 OF 3. (B)(6) HOSPITAL REPORTED PATIENT SURGICAL INFECTION(S). THE HOSPITAL HAS NOT IDENTIFIED THE REPORTED LUMBAR DECOMPRESSION KIT IS THE SOURCE; HOWEVER, IT IS ONE OF THE DEVICES WHICH WAS UTILIZED DURING PROCEDURE(S). ADDITIONAL INFORMATION WAS RECEIVED ON 01AUG2022 THAT STATES, THERE WAS A TOTAL OF THREE PACKS USED DURING SURGERY WITH THE SAME LOT NUMBER (843221). THIS OCCURRED WITH THREE DIFFERENT PATIENTS THAT DEVELOPED INFECTIONS. ALL INFORMATION REASONABLY KNOWN AS OF 08AUG2022 HAS BEEN INCLUDED IN THIS MEDICAL DEVICE REPORT. THE INFORMATION PROVIDED BY O&M HALYARD, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. "AFTER A THOROUGH INVESTIGATION WITH THE TEAM, INCLUDING PROCESS, SYSTEM, RECORDS, AND EVALUATION, NO IMMEDIATE CAUSE COULD BE IDENTIFIED, THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. IT IS NOTEWORTHY THAT THE COMPLAINANT IDENTIFIED AN INFECTION; THEREFORE, AS PART OF THE INVESTIGATION, WOULD INCLUDE A REQUEST FOR THE TRAY SUPPLIER TO CONDUCT AN INTERNAL INVESTIGATION." ALL INFORMATION REASONABLY KNOWN AS OF 28 SEP 2022 HAS BEEN INCLUDED IN THIS MEDICAL DEVICE REPORT. THE INFORMATION PROVIDED BY O&M HALYARD, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    PATIENT # 2 OF 3. (B)(6) HOSPITAL REPORTED PATIENT SURGICAL INFECTION(S). THE HOSPITAL HAS NOT IDENTIFIED THE REPORTED LUMBAR DECOMPRESSION KIT IS THE SOURCE; HOWEVER, IT IS ONE OF THE DEVICES WHICH WAS UTILIZED DURING PROCEDURE(S). ADDITIONAL INFORMATION WAS RECEIVED ON 01AUG2022 THAT STATES, THERE WAS A TOTAL OF THREE PACKS USED DURING SURGERY WITH THE SAME LOT NUMBER (843221). THIS OCCURRED WITH THREE DIFFERENT PATIENTS THAT DEVELOPED INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2025806 LUMBAR DECOMPRESSION (ISLD70) LUMBAR DECOMPRESSION (ISLD70) OJG AMERICAN CONTRACT SYSTEMS ISLD70G 843221 09501101020016

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other