FDA Adverse Event
Other
Summary report: N
GERONIMO 107PR
MDR report key: 140338
·
Received December 26, 1997
Report
- Report Number
- 2025750-1997-00002
- Event Type
- Other
- Date Received
- December 26, 1997
- Report Date
- December 23, 1997
- Manufacturer
- REDMAN, INC.
- Product Code
- ITI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
LETTER FROM AN ATTORNEY AT LAW. ALLEDGED BROKEN ANKLE IN TWO PLACES, ON TWO DIFFERENT OCCASIONS. DATE OF LETTER 12/18/97. CO LOGS EVERY PHONE CALL MESSAGE. NO RECORD OF ANY CALLS FROM PT. NO COMPLAINT OPENED, AS CO WAS NOT INFORMED OF THIS ALLEDGED INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GERONIMO 107PR | DIRECT DRIVE POWER CHAIR | ITI | REDMAN, INC. | 107PR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other| S |