BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARP

    MDR report key: 1355033 · Received March 27, 2009

    Report

    Report Number
    3001237153-2009-00001
    Event Type
    Other
    Date Received
    March 27, 2009
    Date of Event
    January 1, 2006
    Report Date
    March 27, 2009
    Manufacturer
    ARP MANUFACTURING LLC
    Product Code
    IPF
    PMA / PMN Number
    K893851
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ARP MFG CONTACTED (B)(4) AND REQUESTED THAT THE CLINIC RETURN THE DEVICE USED ON COMPLAINANT TO ARP MFG FOR TESTING. UPON ITS RECEIPT, THE DEVICE WAS EXTENSIVELY TESTED/EVALUATED BY ARP MFG AND FOUND TO BE OPERATING WITHIN MANUFACTURER AND DEVICE SPECIFICATIONS. IN CONCLUSION, ARP MFG'S ORIGINAL AND ADDITIONAL INVESTIGATION INTO THIS COMPLAINT SHOW THAT, DESPITE NUMEROUS REQUESTS, THE COMPLAINANT HAS REFUSED TO PROVIDE MEDICAL EVIDENCE TO SUBSTANTIATE ANY CLAIM OF INJURY BASED ON THE CLAIM OF INAPPROPRIATE USE OF THE DEVICE. OUR INVESTIGATION INTO THE CLINIC DETERMINED THAT THE DEVICE WAS USED WITHIN LABEL CLAIMS AND DEVICE SPECIFICATIONS. FURTHER, EXTENSIVE TESTING OF THE DEVICE ALSO ESTABLISHES THAT THE UNIT PERFORMED WITHIN SPECIFICATIONS. OUR INVESTIGATION ALSO DETERMINES THE COMPLAINANT WAS INTERESTED IN BECOMING AN INDEPENDENT SALES REPRESENTATIVE FOR THE DEVICE AND AN OPERATOR OF HER OWN CLINIC, WHICH WAS DENIED. WE HAVE CONCLUDED THAT NO INJURY OCCURRED IN THIS INCIDENT. CONSEQUENTLY, ARP MFG'S EARLIER INVESTIGATION AND CONCLUSION THAT THE DEVICE AT ISSUE OPERATED PROPERLY, WITHIN MANUFACTURER SPECIFICATIONS AND THAT NO OCCURRENCE OF INJURY TOOK PLACE AT THE CLINIC LEVEL, REMAINS UNDISTURBED.

    Description of Event or Problem · 1

    ON (B)(6), 2008, ARP MANUFACTURING, (B)(4), RECEIVED A TELEPHONE CALL FROM A FEMALE COMPLAINANT WHO STATED THAT SHE WAS TREATED IN 2006 AT THE (B)(6). THE COMPLAINANT BELIEVED THAT HER AUTONOMIC SYSTEM WAS NEGATIVELY AFFECTED AFTER TREATMENT WITH A POWERED MUSCLE STIMULATOR PRODUCED BY ARP MFG. THE COMPLAINANT STATED THAT SHE DID NOT BELIEVE THAT THE DEVICE ITSELF MALFUNCTIONED IN ANYWAY, AND, ON THE WHOLE, THOUGHT THAT THE DEVICE WAS "WONDERFUL" IN TERMS OF ITS CAPABILITY AND OVERALL FUNCTION. HOWEVER, THE COMPLAINANT MAINTAINED THAT IN THE COURSE OF HER TREATMENT THE CLINIC DID NOT USE THE DEVICE PROPERLY. ARP MFG REQUESTED THAT SHE COMPLETE A COMPLAINT FORM TO SPECIFICALLY DESCRIBE THE EVENTS AND SUBMIT IT TO THE COMPANY OR FDA, BUT SHE DECLINED TO FOLLOW THROUGH WITH THE REQUIRED PROCEDURE. THIS TELEPHONE CONVERSATION WAS THE FIRST AND ONLY CONTACT INITIATED BY THE COMPLAINANT WITH ARP MFG. SUBSEQUENTLY, DISCUSSIONS WITH THE INDIVIDUALS ADMINISTRATING TREATMENT TO THE COMPLAINANT REVEALED THAT CLINIC STAFF USED THE ARP DEVICE PROPERLY, AS INDICATED WITHIN CLEARED LABEL CLAIMS AND DEVICE SPECIFICATIONS. THE INDIVIDUALS WHO ADMINISTERED THE TREATMENT TO THE COMPLAINANT CLEARLY RECALL THE INDIVIDUAL AND HER COURSE OF TREATMENT. ARP MFG IS UNAWARE OF A COMPLAINT LODGED WITH THE CLINIC IN 2006 REGARDING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARP POWERED MUSCLE STIMULATOR IPF ARP MANUFACTURING LLC 100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other