FDA Adverse Event
Other
Summary report: N
GUARDIAN
MDR report key: 193131
·
Received October 23, 1998
Report
- Report Number
- 2020334-1998-00021
- Event Type
- Other
- Date Received
- October 23, 1998
- Date of Event
- September 22, 1998
- Report Date
- October 22, 1998
- Manufacturer
- SUNRISE MEDICAL TECNOLOGIAS
- Product Code
- INN
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT END USER SAT DOWN ON CHAIR AND ONE REAR LEG BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUARDIAN | SHOWER CHAIR | INN | SUNRISE MEDICAL TECNOLOGIAS | 30400 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other |