D
Patient 1
PT SLID OFF THE FOOT STEP AND CUT HER LEG ON THE FOOT STEP FRONT REQUIRING NINE STITCHES. THERE IS A SHARP EDGE TO THE FOOT STEP FRONT. THE PT WAS NOT VERY MOBILE, REQUIRED A CAREGIVER TO HELP HER.
MAUDE MDR 1864778
- MDR report key
- 1864778
- Report number
- 1523530-2010-00009
- Event key
- 0
- Event type
- 3
- Date of event
- 2010-09-10
- Date received
- 2010-10-06
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- DONALD CARR
- Address
- 60 VISTA DR. VERSAILLES OH 45380 US
- Phone
- 937-937-9375
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | RITTER | CHAIR, BLOOD DONOR | MIDMARK CORP. | FML | 104-035 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2010-10-06 | 0 | 1. R |
Event Narratives#
N
Patient 1
THE EXAM TABLE INVOLVED IN THE INCIDENT WAS 30 YEARS OLD. AN INDEPENDENT SERVICE TECH WAS SENT TO EVALUATE THE TABLE. THE TECH REPORTED THAT THE EDGE BANDING ON THE STEP FRONT WAS MISSING. WE BELIEVE THE MISSING BANDING CONTRIBUTED TO THIS INCIDENT.