D
Patient 1
CUSTOMER DEVELOPED A RASH AFTER WEARING THE THUMB CMC RESTRICTION SPLINT FOR FOUR DAYS. THE SPLINT IS A LATEX FREE PRODUCT.
MAUDE MDR 2249645
- MDR report key
- 2249645
- Report number
- 2939821-2011-00011
- Event key
- 0
- Event type
- 3
- Date of event
- 2009-01-09
- Date received
- 2011-08-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- DAN LYNCH
- Address
- 8100 CAMINO ARROYO GILROY CA 95020 US
- Phone
- 408-408-4087
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | COMFORT COOL THUMB CMC RESTRICTION SPLINT | THUMB CMC RESTRICTION SPLINT | NORTH COAST MEDICAL, GILROY | ILI | NA | NC79564 | NA | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-08-26 | 0 | 1. O |
Event Narratives#
N
Patient 1
ADD'L CATALOG# NC79565.