FDA Adverse Event
Other
Summary report: N
THERMAL LIGATING SHEARS
MDR report key: 3027601
·
Received March 27, 2013
Report
- Report Number
- 1223422-2013-00014
- Event Type
- Other
- Date Received
- March 27, 2013
- Report Date
- March 25, 2013
- Manufacturer
- MICROLINE SURGICAL INC.
- Product Code
- GEI
- PMA / PMN Number
- K062257
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE WHITE ON THE JAWS WAS DAMAGED DURING USE. THE PATIENT HAS NOT BEEN HARMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 127079 | THERMAL LIGATING SHEARS | STLS 23C | GEI | MICROLINE SURGICAL INC. | 102-137D | 010002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |