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

Model Number 410200

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2021

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 230141119
• Report Number: MW5099069
• Device Sequence Number: 1
• Product Code: NGX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: 410200
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 73