FDA Adverse Event
Malfunction
Summary report: N
3612 LITE GLOVE
MDR report key: 1374112
·
Received February 17, 2009
Report
- Report Number
- 1282497-2009-00005
- Event Type
- Malfunction
- Date Received
- February 17, 2009
- Report Date
- February 10, 2009
- Manufacturer
- COVIDIEN
- Product Code
- FQP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B) (4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON 02/10/2009 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER REPORTS THE LITE GLOVE WAS SPLIT DOWN THE CENTER OF THE HANDLE, EXPOSING THE ADAPTER. PHYSICIANS RE-DRAPED IN THE MIDDLE OF THE PROCEDURE TO PREVENT CONTAMINATION OF THE STERILE FIELD. THE PT WAS GIVEN PRECAUTIONARY ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3612 LITE GLOVE | LITE GLOVE | FQP | COVIDIEN | 31140257 | 8165203 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |