D
Patient 1
GUIDE WIRE REPORTEDLY UNRAVELED AND BROKE. A PIECE OF WIRE WAS LEFT IN THE PT'S SKIN. NO PT COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFO WAS AVAILABLE.
MAUDE MDR 2045581
- MDR report key
- 2045581
- Report number
- 1649395-2011-00004
- Event key
- 0
- Event type
- 3
- Date of event
- 2010-06-29
- Date received
- 2011-02-28
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- BETSY CORTELLONI
- Address
- 2220 MERRITT DR. GARLAND TX 75041 US
- Phone
- 770-770-7708
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | GALT NITINOL WIRE | GUIDE WIRE | GALT MEDICAL | DQX | SGW-019-34 | UNK | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-02-28 | 0 |
Event Narratives#
N
Patient 1
DEVICE WAS NOT AVAILABLE FOR EVAL. DEVICE LOT NUMBER WAS UNK. THE DEVICE HISTORY RECORDS FOR THREE POTENTIAL LOTS WERE REVIEWED AND NO OUT OF SPECIFICATION CONDITIONS WERE NOTED.