N
Patient 1
NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. INVESTIGATION OF ISSUE ALREADY COMPLETED RESULTING IN A NEGLIGIBLE INCIDENCE RATE. MANUFACTURING PROCESS IMPROVEMENT ALREADY IMPLEMENTED TO PREVENT RECURRENCE.
MAUDE MDR 6988868
- MDR report key
- 6988868
- Report number
- 2028253-2017-00078
- Event key
- 0
- Event type
- 3
- Date received
- 2017-10-30
- 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#
- Contact
- MRS. CAROL EMERSON
- Address
- 2885 LOKER AVENUE EAST CARLSBAD CA 92010 US
- Phone
- 760-760-7607
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JWALKER BOOT | JWALKER BOOT | BREG, INC. | IQI | BL210007 | BL210007 | N | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-10-30 | 0 |
Event Narratives#
D
Patient 1
REPORTED INCIDENT OF SOLE SEPARATING FROM BOOT. NO REPORT OF INJURY INVOLVED WITH INCIDENT.