D
Patient 1
INAPPROPRIATE USE OF DOLORCLAST ON PT WRIST WITH IRREVERSIBLE DAMAGE.
MAUDE MDR 1482200
- MDR report key
- 1482200
- Report number
- 3004096429-2009-00001
- Event key
- 0
- Event type
- 3
- Date received
- 2009-09-16
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Address
- 31 CH. DE LA VUARPILLIERE NYON 1260 SZ
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DOLORCLAST | SHOCKWAVE GENERATOR FOR PAIN RELIEF | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. | NBN | UNK | UNK | UNK | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-09-16 | 0 | 1. S |
Event Narratives#
N
Patient 1
DOLORCLAST IS AN EXTRA CORPOREAL SHOCK WAVE DEVICE INTENDED FOR USE IN TREATING SOFT TISSUE ORTHOPEDIC DISEASES. DOLORCLAST IS INTENDED FOR TREATMENT OF CHRONIC PROXIMALPLANTAR FASCIITIS.