MAUDE Adverse Event Report: BEMER USA, LLC BEMER PRO-SET; STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING

Model Number	410200
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
I received an email from bemer usa, llc titled "urgent: medical device correction" stating that the product manufacturer has become aware of cases in which a causal link between the use of the bemer therapy system and a technical defect in an insulin pump could not be ruled out with absolute certainty.I am an insulin-dependant type 1 diabetic, and the email states i have an "absolute contraindication, which means that the bemer therapy system may no longer be used." i can see this product has been recalled in (b)(6), but is not listed on the fda site.I am wondering if the fda is aware, and if there are remedies offered for consumers who are now being told they absolutely should not use these devices.As of today, no remedy has been offered by the manufacturer.To be clear, i have not experienced an adverse event.I have been told to cease use of a very expensive medical device, by the manufacturer, due to contraindications.Thank you.Fda safety report id# (b)(4).

• Brand Name: BEMER PRO-SET
• Common Device Name: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• Manufacturer (Section D): BEMER USA, LLC ; 1989 palomar oaks way; ste a; carlsbad CA 92011
• MDR Report Key: 11243741
• Report Number: MW5099069
• Device Sequence Number: 13771620
• Product Code: NGX
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 410200
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2021
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 73