FDA Adverse Event
Other
Summary report: N
3612 LITE GLOVE
MDR report key: 3999026
·
Received August 5, 2014
Report
- Report Number
- 9612030-2014-00042
- Event Type
- Other
- Date Received
- August 5, 2014
- Report Date
- August 1, 2014
- Manufacturer
- COVIDIEN
- Product Code
- FQP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- 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) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER REPORTS THAT DURING AN ORTHOPEDIC SURGERY, THE LITE GLOVE BECAME LOOSE IN TWO PARTS. THE CUSTOMER FURTHER REPORTS THAT THE LITE GLOVE WAS TORN AND IT WAS NOTED AT THE END OF THE SURGERY. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AS A RESULT OF THIS INCIDENT. THIS INCIDENT DID NOT PROLONG THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 456050 | 3612 LITE GLOVE | LITE GLOVE | FQP | COVIDIEN | 31140257 | 3283100664X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |