D
Patient 1
RECEIVED CUSTOMER COMPLAINT THAT ONE OF THEIR PT GOT SLAPPED ON THE FACE WHEN A LEVEL 3 EXERCISE BAND SNAPPED.
MAUDE MDR 2640028
- MDR report key
- 2640028
- Report number
- 2939821-2011-00014
- Event key
- 0
- Event type
- 3
- Date of event
- 2009-08-21
- 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
- 3
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 | NC EXERCISE BAND, LEVEL 3 | EXERCISE BAND | THAI CENTRI CO, LTD | ION | NA | NC91221-50 | NA | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-08-26 | 0 | 1. O |
Event Narratives#
N
Patient 1
CATALOG NUMBERS: NC 91223-50 AND NC91225-50.