MU-4

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-05 for MU-4 manufactured by Tens Plus Industrial Company.

Event Text Entries

[122835974] Therapist applied electric stimulation to a patient's lower back (excel unit, interferential setting 80-150 hz) combined with moist heat. Patient was in sitting position. I increased the intensity of the estim to within patient's comfort level verbalized to me (approx. Upper 30s in ma) after approximately 3 minutes of treatment, the patient stated he was uncomfortable (pt. Motioned himself forward in the chair) and that the intensity of the machine had suddenly increased on it's own. I turned the estim machine off immediately, noting the intensity was at 55 ma. Patient stated he was ok. I checked patient's skin at area of therapy, which was intact. Patient noted that lower right pad was the one that was uncomfortable. I asked if patient wanted to resume remainder of estim rx or stop. Patient stated he was comfortable with continuing the remainder of estim rx. I applied new electrodes and utilized the other side of the unit for estim. Patient was able to complete the remaining 12 minutes of treatment without any problems or discomfort. Skin intact post treatment. Ut post-it note on estim machine to not be used until checked by clinical engineering. Phoned clinical engineering to report this and have estim machine checked.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7937827
• MDR Report Key: 7937827
• Date Received: 2018-10-05
• Date of Report: 2018-09-28
• Date of Event: 2018-03-23
• Report Date: 2018-09-28
• Date Reported to FDA: 2018-09-28
• Date Reported to Mfgr: 2018-10-05
• Date Added to Maude: 2018-10-05
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Generic Name: STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
• Product Code: GZJ
• Date Received: 2018-10-05
• Model Number: MU-4
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TENS PLUS INDUSTRIAL COMPANY
• Manufacturer Address: 230 LIBBEY PKWY. EAST WEYMOUTH MA 02189 US 02189

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-10-05