BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFENET BONE RECOVERY PACK OR SKIN RECOVERY PACK

    MDR report key: 23077655 · Received September 17, 2025

    Report

    Report Number
    1047429-2025-00003
    Event Type
    Injury
    Date Received
    September 17, 2025
    Date of Event
    August 20, 2025
    Report Date
    October 14, 2025
    Manufacturer
    AVID MEDICAL. INC.
    Product Code
    LRO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE 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 PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DETAILS WERE FORWARDED TO THE APPROPRIATE FUNCTIONAL AREA FOR INVESTIGATION AND ROOT CAUSE DETERMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) FOR THE TWO REPORTED POTENTIAL LOT NUMBERS WAS COMPLETED. NO NEEDLES WERE INCORPORATED INTO THE BILL OF MATERIALS (BOM) FOR EITHER LOT. EACH KIT CONTAINS MULTIPLE GOWNS, AND NO NONCONFORMANCES WERE DOCUMENTED DURING THE MANUFACTURING PROCESS. THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE CONFIRMED TO BE ASSOCIATED WITH AVID CONVENIENCE KIT MANUFACTURING. THE REPORTED LOTS DID NOT CONTAIN ANY NEEDLES, AND IT HAS BEEN VERIFIED THAT GOWNS AND NEEDLES ARE STORED IN SEPARATE DESIGNATED WAREHOUSE LOCATIONS, MAKING THE LIKELIHOOD OF A MISPICK AND SUBSEQUENT INCLUSION IN A KIT HIGHLY IMPROBABLE. BIN LOCATIONS FOR THE GOWNS WERE INSPECTED, AND NO ISSUES OR EVIDENCE OF MIXED COMPONENTS WERE IDENTIFIED. THE REPORTED COMPLAINT HAS BEEN ENTERED IN OUR TRACKING AND TRENDING PROGRAM IN ORDER TO MONITOR FOR EMERGING TRENDS IN THE MARKETPLACE. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE 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 PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A NEEDLE WAS FOUND IN A GOWN CONTAINED WITHIN AVID MEDICAL CUSTOMER PROCEDURE TRAY. THIS RESULTED IN AN EMPLOYEE INJURY (LACERATION). TWO LOT NUMBERS WERE INITIALLY IDENTIFIED AS POSSIBLE COMPLAINT PRODUCT. AVID LOT NUMBERS REPORTED ARE 1602636 LIFENET BONE RECOVERY PACK AND 1613503 SKIN RECOVERY PACK. IT IS IMPORTANT TO NOTE THAT NO NEEDLES ARE INCLUDED IN EITHER OF THESE KIT LOTS MANUFACTURED BY AVID MEDICAL. THE EMPLOYEE WAS RECOVERING TISSUE WHEN THE INCIDENT OCCURRED. MEDICAL TREATMENT WAS REQUIRED, ALTHOUGH THE REPORTER DID NOT PROVIDE FURTHER DETAILS. ADDITIONAL INFORMATION WAS REQUESTED ON AUGUST 26, 2025, AUGUST 28, 2025, SEPTEMBER 2, 2025, WITH NO RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2640836 LIFENET BONE RECOVERY PACK OR SKIN RECOVERY PACK LIFENET BONE RECOVERY PACK OR SKIN RECOVERY PACK LRO AVID MEDICAL. INC. AV10657-29 OR LIFE0081-18 1602636 OR 1613503

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other