MW5058129
Report
- Report Number
- MW5058129
- Event Type
- Injury
- Date Received
- November 23, 2015
- Date of Event
- September 15, 2015
- Report Date
- November 23, 2015
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MI, US
- Reporter Occupation
- PATIENT
Narratives
ADD'L INFO RECEIVED FROM REPORTER ON 01/12/2016. TINGLING SENSATION IN CALVES. I COULD NOT SLEEP FOR MANY NIGHTS FOLLOWING USE OF DEVICE DUE TO MUSCLE SPASMS (TWITCHING) OF CALVES AND LOWER BACK. ALSO HAPPENING VARIOUS TIMES DURING THE DAY. I EXPERIENCED WEAKNESS AND LACK OF COORDINATION. SOMETIMES FEELING I WAS GOING TO DROP AND NEEDED SUPPORT. LATER I HAD MUSCLE CRAMPING PROBLEMS AS WELL. I ADVISED (B)(6) BEFORE HAND. I DID NOT WANT ANY ELECTRO STIM. HE DID NOT HEED WARNING. TOLD HIM I HAD BAD RESULTS IN PAST. TEN UNITS. PHYSICAL THERAPY: (B)(6) 2015, (B)(6) 2015. (B)(6).
REPORTER WAS TREATED AT THE PHYSICAL THERAPIST'S OFFICE BY USE OF INTERFERENTIAL CURRENT AT HIS LOWER BACK. HE EXPERIENCED TINGLING AT HIS LOWER LEG AND CALF. MUSCLE SPASMS AT HIS LOWER BACK. THIS DISCOMFORT KEEPS HIM AWAKE. HE SUSPECTS NERVE DAMAGE RESULTING TO NEUROPATHY.
ADD'L INFO RECEIVED FROM MFR ON 12/29/2015: WE AT DJO, LLC HAVE RECEIVED AND REVIEWED MW5058129: OUR REVIEW TEAM WAS ABLE TO CONTACT THE PT, AND CLINIC WITH THE PT PERMISSION FOR ADD'L DETAILS. PER THE PT RESPONDING TO OUR REQUEST, THE UNIT INVOLVED WITH THIS EVENT WAS NOT A DJO, LLC DEVICE. THE DATA GIVEN FOR THE DEVICE IS AS FOLLOWS: MFR: HENLEY INTERNATIONAL; BRAND NAME: ENDOMED 433, RISK CLASS 2G; MODEL # 1433.902; SERIAL # (B)(4),
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 0 | Other |