MAUDE Adverse Event Report: MTS MEDICAL UG TRT ORTHOGOLD 100 STEMWAVE THERAPY; MASSAGER, THERAPEUTIC, ELECTRIC

Device Problems Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Burning Sensation (2146); Inadequate Pain Relief (2388); Numbness (2415)

Event Date 01/24/2022

Event Type  Injury  

Event Description

Patient called to report an adverse event involving the orthogold 100 therapy device used on her by her chiropractor in late (b)(6) 2022.Patient stated she had 3 treatments a day or two apart in late (b)(6), the first one she described as a slight numbing feeling and was told by her chiropractor that it was set on a low level.Patient stated the second treatment was about the same as the first, a slight numbing feeling described as an elevated feeling.Patient stated for the third treatment, her chiropractor told her they were going to turn the device up to a level 5, and at the time the patient said she felt an electric stimulation that wasn't terrible at first but became intensely worse a couple days later.Patient stated the pain after the third treatment felt like terrible frostbite all over her entire body, was extremely painful, freezing, like burning numbness.Patient stated she was treated with this device to help her preexisting neuropathy; however, it severely aggravated her neuropathy instead and caused her very intense, excruciating pain that she is still dealing with.Patient does not think this device should be used as treatment for neuropathy as it can severely exacerbate the condition instead of help it.Patient said she received the 3 treatments on the bottom of her feet and her calves.

• Brand Name: TRT ORTHOGOLD 100 STEMWAVE THERAPY
• Type of Device: MASSAGER, THERAPEUTIC, ELECTRIC
• Manufacturer (Section D): MTS MEDICAL UG
• MDR Report Key: 13417999
• MDR Text Key: 284889910
• Report Number: MW5107111
• Device Sequence Number: 1
• Product Code: ISA
• Combination Product (y/n): N
• 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: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Sex: Female