FDA Adverse Event
Other
Summary report: N
INTELECT MOBILE 2CH STIM
MDR report key: 1060938
·
Received June 11, 2008
Report
- Report Number
- 1022819-2008-00168
- Event Type
- Other
- Date Received
- June 11, 2008
- Date of Event
- May 22, 2008
- Report Date
- May 29, 2008
- Manufacturer
- CHATTANOOGA GROUP
- Product Code
- IPF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
AWAITING DEVICE RETURN AND EVAL.
Description of Event or Problem · 1
THE PT WAS BEING TREATED IN THE THIGH AND BACK AREA. DURING THE TREATMENT THE PT REPORTED A BURNING SENSATION. IT IS EXPECTED THAT THE CLINICIAN TERMINATED THE TREATMENT UPON THE NOTIFICATION OF THE PT DISCOMFORT. THE CLINICIAN HAD PRESCRIBED THE PREMOD AND MODALITIES FOR THE PATIENT'S SYMPTOMS. THE TREATMENT TIME FOR THE PREMOD WAVEFORM WAS SET TO 20 MINUTES. THE TREATMENT TIME FOR THE RUSSIAN WAVEFORM WAS SET FOR 30 MINUTES. THE CLINICIAN HAD PRESCRIBED THE USE OF CARBON ELECTRODES TO APPLY THE WAVEFORMS. THE DEGREE OF PT INJURY WAS NOT PROVIDED BY THE REPORTING CLINICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELECT MOBILE 2CH STIM | POWER MUSCLE STIMULATOR | IPF | CHATTANOOGA GROUP | 2777 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |