FDA Adverse Event
Malfunction
Summary report: N
3612 LITE GLOVE
MDR report key: 3043453
·
Received March 12, 2013
Report
- Report Number
- 1282497-2013-00005
- Event Type
- Malfunction
- Date Received
- March 12, 2013
- Date of Event
- February 12, 2013
- Report Date
- February 18, 2013
- Manufacturer
- COVIDIEN
- Product Code
- FQP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2013. 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 LITE GLOVE. THE REPRESENTATIVE REPORTS THAT AFTER A SPINAL SURGERY WITH IMPLANTATION HAD COMMENCED, A SPLIT IN THE LITTLE GLOVE WAS NOTICED. THE PT WAS GIVEN CEPHALEXIN IV DURING THEIR STAY IN THE HOSPITAL AND WAS PRESCRIBED CEFACLORE FOR 5 DAYS UPON BEING DISCHARGED SINCE THE EXACT POINT AT WHICH THE SPLIT OCCURRED WAS UNK. THESE MEDICATIONS WERE GIVEN TO THE PT AS A PRECAUTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 104383 | 3612 LITE GLOVE | LITE GLOVE | FQP | COVIDIEN | 31140257 | 2051173 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |