FDA Adverse Event
Injury
Summary report: N
VECTRA GEN 2C COMBO
MDR report key: 2051034
·
Received April 4, 2011
Report
- Report Number
- 9616086-2011-00060
- Event Type
- Injury
- Date Received
- April 4, 2011
- Date of Event
- March 9, 2011
- Report Date
- April 4, 2011
- Manufacturer
- DJ ORTHOPEDICS DE MEXICO
- Product Code
- IMG
- PMA / PMN Number
- K040285
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT RETURNED TO HOSPITAL AFTER TREATMENT WITH BURNS, SEVERITY NOT KNOWN. INVESTIGATION ONGOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VECTRA GEN 2C COMBO | COMBO ELECTROTHERAPY/ULTRASOUND | IMG | DJ ORTHOPEDICS DE MEXICO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |