FDA Adverse Event
Other
Summary report: N
GUARDIAN
MDR report key: 187507
·
Received September 17, 1998
Report
- Report Number
- 2020334-1998-00017
- Event Type
- Other
- Date Received
- September 17, 1998
- Date of Event
- October 1, 1997
- Report Date
- September 15, 1998
- Manufacturer
- SUNRISE MEDICAL PCP DIV
- Product Code
- INP
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT IS REPORTED THAT THE END USER WAS APPROACHING THE WALKER WITH THE PALTFORM ATTACHED. SHE APPLIED HER WEIGHT TO THE PLATFORM ATTACHMENT, THEN THE POST BROKE CAUSING HER TO FALL AND FRACTURE TWO RIBS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUARDIAN | WALKER PLATFORM ATTACHMENT | INP | SUNRISE MEDICAL PCP DIV | 7702 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |