BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX ACP TM DOUBLE SYRINGE

    MDR report key: 19633194 · Received June 28, 2024

    Report

    Report Number
    1220246-2024-06497
    Event Type
    Injury
    Date Received
    June 28, 2024
    Date of Event
    June 10, 2024
    Report Date
    August 16, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    FMF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, D9, G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE THAT THE COMPLAINT ALLEGATION IS NOT CONFIRMED AS IT IS NOT PRODUCT RELATED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    UPDATE (B)(6) 18-JUL-2024: FURTHER INFORMATION WERE PROVIDED THAT THE SURGEON DUG DEEPER WITH THE PATIENT AND BELIEVED THAT THE RASH WAS NOT DUE TO THE PRP INJECTION. THE PATIENT MENTIONED THAT THEY HAD A SMALL RASH PRIOR TO THE ACP INJECTION AND SO IT WAS JUST COINCIDENCE THAT THE RASH OCCURRED AT THE SAME TIME. THE CONSULTANT DOES NOT BELIEVE THE ACP PRP INJECTION CAUSED THE RASH; IT WAS CAUSED BY ANOTHER FACTOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT POST ACP INJECTION THE PATIENT DEVELOPED A RASH. NO FURTHER INFORMATION WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2175375 ARTHREX ACP TM DOUBLE SYRINGE SYRINGE, PISTON FMF ARTHREX, INC. ARTHREX ACP TM DOUBLE SYRINGE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other