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 5827053
- MDR report key
- 5827053
- Report number
- 3011137372-2016-00235
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-05-16
- Date received
- 2016-07-27
- 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 | SCIS IRIS STR S/S 4.5" | SCISSORS,OPHTHALMIC | TELEFLEX MEDICAL | HNF | 144300 | 05-1450 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-07-27 | 0 |
Event Narratives#
D
Patient 1
THE RADIOLOGIST USED THE SCISSORS TO REMOVE SOME FIBRIN IN A WOUND BED; THE TIP BROKE AND DROPPED IN THE WOUND. HE WAS ABLE TO RETRIEVE THE BROKEN PIECE. THE PATIENT'S CONDITION WAS REPORTED AS FINE.
N
Patient 1
(B)(4). THIS COMPLAINT IS VOIDED, BECAUSE THE PRODUCT THAT WAS SENT BY THE CUSTOMER, CONCERNING THE REPORTED DEFECT IS NOT A TELEFLEX PRODUCT.
D
Patient 1
THE RADIOLOGIST USED THE SCISSORS TO REMOVE SOME FIBRIN IN A WOUND BED; THE TIP BROKE AND DROPPED IN THE WOUND. HE WAS ABLE TO RETRIEVE THE BROKEN PIECE. THE PATIENT'S CONDITION WAS REPORTED AS FINE.