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 Number7937827
MDR Report Key7937827
Date Received2018-10-05
Date of Report2018-09-28
Date of Event2018-03-23
Report Date2018-09-28
Date Reported to FDA2018-09-28
Date Reported to Mfgr2018-10-05
Date Added to Maude2018-10-05
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
Product CodeGZJ
Date Received2018-10-05
Model NumberMU-4
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerTENS PLUS INDUSTRIAL COMPANY
Manufacturer Address230 LIBBEY PKWY. EAST WEYMOUTH MA 02189 US 02189


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-05

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