FDA Adverse Event
Summary report: N
INTELECT MOBILE US
MDR report key: 2112489
·
Received March 29, 2011
Report
- Report Number
- 9616086-2011-00033
- Date Received
- March 29, 2011
- Date of Event
- February 24, 2011
- Report Date
- March 24, 2011
- Manufacturer
- DJ ORTHOPEDICS DE MEXICO
- Product Code
- IMG
- PMA / PMN Number
- K841445
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING USE, 2 PATIENTS FELT A DEEP PAIN. THIS LEAD TO THE FIRST PATIENT IN A VAGAL FAINTNESS AND THE SECOND TO A ROARING PAIN. INVESTIGATION PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELECT MOBILE US | ELECTROTHERAPY | IMG | DJ ORTHOPEDICS DE MEXICO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |