BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPONGE SPECIALTY K-DISS XR 100-CS

    MDR report key: 20732699 · Received November 20, 2024

    Report

    Report Number
    1030451-2024-00022
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    October 10, 2024
    Report Date
    February 6, 2025
    Manufacturer
    MEDICAL ACTION INDUSTRIES
    Product Code
    GDY
    UDI-DI
    20809160015633
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL ACTION INDUSTRIES REPACKAGES THE SPONGES PROVIDED BY CARWILD. MEDICAL ACTION INDUSTRIES HAS NO OTHER COMPLAINTS FOR THIS ISSUE RECEIVED IN THE PAST THREE YEARS. CARWILD PERFORMED AN INVESTIGATION OF SPONGE LOT NUMBER. DEVICE HISTORY RECORD WAS REVIEWED, THERE WERE NO FINDINGS. NO DEVIATIONS WERE REPORTED DURING MANUFACTURE. RAW MATERIALS AND MANUFACTURING EQUIPMENT WERE REVIEWED. THERE WERE NO CHANGES OR ISSUES NOTED. A ROOT CAUSE WAS NOT ESTABLISHED, THIS APPEARS TO BE AN ISOLATED INCIDENT. 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 HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THIS EVENT IS AVAILABLE FOR EVALUATION. THE COMPLAINT COMPONENT SPONGE KITTER DISSECTOR PART NUMBER 9160-02 IS MANUFACTURED BY CARWILD CORPORATION (FDA REGISTRATION 1219313). A SCAR WAS ISSUED TO THE SUPPLIER ON (B)(6) 2024. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION AND RESPONSE BY THE SUPPLIER. 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 HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    THE DOCTOR REPORTED THE SPONGES WERE UNRAVELING AND FLAKING INTO LITTLE PIECES. THE INCIDENT WAS IDENTIFIED DURING THYROID SURGERY AND THE SURGERY WAS PROLONGED AS A RESULT OF THE ISSUE. THE SURGEON PICKED ALL THE LITTLE PIECES OUT OF THE WOUND WHICH TOOK TIME AND INTRICACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1996606 SPONGE SPECIALTY K-DISS XR 100-CS SPONGE SPECIALTY K-DISS XR 100-CS GDY MEDICAL ACTION INDUSTRIES 7102 319552 20809160015633

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other