N
Patient 1
(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
MAUDE MDR 5531835
- MDR report key
- 5531835
- Report number
- 3011137372-2016-00052
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-02-19
- Date received
- 2016-03-29
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- JASMINE BROWN
- Address
- 3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US
- Phone
- 919-919-9193
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | OLSEN HEGAR 6.5" INSERT | HOLDER,NEEDLE;ORTHOPEDIC | TELEFLEX MEDICAL | HXK | 510445 | H2 | R | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-03-29 | 0 |
Event Narratives#
D
Patient 1
ALLEGED EVENT: A PART OF THE NEEDLE HOLDER BROKE OFF AND FELL INTO THE DOG. THE PIECE WAS RETRIEVED AND THERE WAS NO HARM TO THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.
N
Patient 1
(B)(4). DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO 510445 SAMPLE OF 510445 WAS RECEIVED FOR EVALUATION. THE BLADE IS BROKEN AT THE PIVOT POINT. RUST AND DRIED BLOOD WERE OBSERVED INSIDE THE FRACTURE PLANE. DUE TO THE REPEAT INCIDENTS WITH THIS CUSTOMER - IT IS LIKELY THAT THIS IS A SITE SPECIFIC ISSUE RELATED TO METHOD OF USE. THERE ARE NO OTHER COMPLAINTS FOR THIS ISSUE. SAMPLE OF 510445 WAS RECEIVED FOR EVALUATION. THE BLADE IS BROKEN AT THE PIVOT POINT. RUST AND DRIED BLOOD WERE OBSERVED INSIDE THE FRACTURE PLANE. PREVIOUS COMPLAINTS WERE SUBMITTED BY THE SAME CUSTOMER.
D
Patient 1
ALLEGED EVENT: A PART OF THE NEEDLE HOLDER BROKE OFF AND FELL INTO THE DOG. THE PIECE WAS RETRIEVED AND THERE WAS NO HARM TO THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.