FDA Adverse Event
Injury
Summary report: N
SUBTALER M.B.A.
MDR report key: 431615
·
Received December 5, 2002
Report
- Report Number
- 2028840-2002-00045
- Event Type
- Injury
- Date Received
- December 5, 2002
- Date of Event
- November 11, 2002
- Report Date
- December 2, 2002
- Manufacturer
- KINETIKOS MEDICAL, INC.
- Product Code
- HRS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON DEC 02, 2002, KMI WAS NOTIFIED OF THE EXPLANT OF A SUBTALAR M.B.A. TO ADDRESS PT PAIN OWING TO POSSIBLE ALLERGIES OR INCORRECT SIZE USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUBTALER M.B.A. | ORTHOPEDIC IMPLANT (FOOT) | HRS | KINETIKOS MEDICAL, INC. | 05-0XXX | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Hospitalization| R |