FDA Adverse Event
Injury
Summary report: N
MIAMI J ADVANCED V2
MDR report key: 6138736
·
Received December 1, 2016
Report
- Report Number
- 3008523132-2016-00006
- Event Type
- Injury
- Date Received
- December 1, 2016
- Report Date
- December 19, 2016
- Manufacturer
- OSSUR
- Product Code
- IQK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
PATIENT WEARING MIAMI J ADVANCED NECK COLLAR IN THE HOSPITAL EXPERIENCED BLISTERING AND SEVERE SKIN BREAKDOWN AT THE CHIN WITH ONE FULL DAYS USE. IRRITATION OCCURED AT THE MANDIBLE SUPPORT.
Description of Event or Problem · 1
PATIENT WEARING MIAMI J ADVANCED NECK COLLAR IN THE HOSPITAL EXPERIENCED BLISTERING AND SEVERE SKIN BREAKDOWN AT THE CHIN WITH ONE FULL DAYS USE. IRRITATION OCCURED AT THE MANDIBLE SUPPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 789946 | MIAMI J ADVANCED V2 | ORTHOSIS, CERVICAL | IQK | OSSUR | MJA-101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |