FDA Adverse Event
Other
Summary report: N
3611 LITE GLOVE
MDR report key: 3608670
·
Received January 23, 2014
Report
- Report Number
- 9612030-2014-00004
- Event Type
- Other
- Date Received
- January 23, 2014
- Report Date
- November 22, 2013
- Manufacturer
- COVIDIEN
- Product Code
- FMC
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- 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)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A HEEL WARMER. THE REP REPORTS THAT A SCRUB NURSE NOTICED THAT THE LITE GLOVE WAS SPLIT AT THE END OF THJR. AS THEY WERE UNSURE OF WHEN THE SPLIT HAPPENED, THEY GAVE THE PT AN ADD'L DOSE OF ANTIBIOTICS. THE PT DID NOT DEVELOP ANY POST-OPERATIVE INFECTION. THERE WAS NO ADVERSE EFFECT TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 54906 | 3611 LITE GLOVE | LITE GLOVE | FMC | COVIDIEN | 31140208 | 123180180X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |