N
Patient 1
NOT RETURNED.
MAUDE MDR 5180336
- MDR report key
- 5180336
- Report number
- 3010811527-2015-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-08-31
- Date received
- 2015-10-27
- 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
- WILLIAM FISHER
- Address
- 1430 DECISION STREET VISTA CA 92081 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 | DR COMFORT | TOE FILLER | DR COMFORT, A DJO LLC COMPANY | KNP | L-5000 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-10-27 | 0 | 1. R |
Event Narratives#
D
Patient 1
COMPLAINT RECEIVED THAT ALLEGES "TOES DONT FIT IN THE SPACE & THE FILLER GAVE HIM AN ULCER W./ FOOT ON ORTHOTIC THE BIG TOE HANGS OFF MEDIALLY MED LESS FILLER LATERALLY. THERE IS BLOOD ON THE ORTHOTIC DEVICE WHERE EXCESS PRESSURE WAS APPLIED CAUSING AN ULCER TO OCCUR". QUESTIONNAIRE WAS NOT RECEIVED FROM CLINICIAN AND/OR PATIENT. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION.