FDA Adverse Event
Summary report: N
ELECTROMYOGRAPH
MDR report key: 11506
·
Received February 3, 1994
Report
- Report Number
- MW4000191
- Date Received
- February 3, 1994
- Report Date
- January 13, 1994
- Manufacturer
- TECH CORP.
- Product Code
- IKN
- Report Source
- Voluntary report
- Reporter Location
- MI, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
RPTR UNDERWENT AN ELECTRODIAGNOSTIC TEST IN WHICH AN ELECTROMYELOGRAPH WAS USED. CONSUMER ALLEGES THAT HE WAS ELECTRICALLY SHOCKED DURING THE TEST. RPTR WAS ON THE EXAMINATION TABLE, AND DR TESTED HIS LOWER BACK FOR 10 SECONDS. HE THEN PROCEEDED TO RPTR'S LEGS, BUT THIS TIME HAD MACHINE SET AT LEVEL OF 10 WHICH LITERALLY WENT THROUGH RPTR'S BODY "IN THE AIR" AND RESULTED IN PINCHING TWO NERVES IN RPTR'S SPINE. MACHINE WAS AN OLD MODEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELECTROMYOGRAPH | IKN | TECH CORP. | 5A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |