FDA Adverse Event
Other
Summary report: N
3612 LITE GLOVE
MDR report key: 4038004
·
Received August 19, 2014
Report
- Report Number
- 9612030-2014-00047
- Event Type
- Other
- Date Received
- August 19, 2014
- Report Date
- August 11, 2014
- Manufacturer
- COVIDIEN
- Product Code
- FQP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER REPORTS THAT THE LITE GLOVE TORE DURING USE. IT WAS NOTICED TOWARD THE END OF THE CASE AND THE PT WAS PRESCRIBED ANTIBIOTICS AS A PRECAUTIONARY MEASURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 499573 | 3612 LITE GLOVE | LITE GLOVE | FQP | COVIDIEN | 31140257 | 4147103364X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |