FDA Adverse Event
Malfunction
Summary report: N
STICK SPONGE PVP PAINT
MDR report key: 3061797
·
Received March 29, 2013
Report
- Report Number
- 9612030-2013-00007
- Event Type
- Malfunction
- Date Received
- March 29, 2013
- Date of Event
- March 5, 2013
- Report Date
- March 6, 2013
- Manufacturer
- COVIDIEN
- Product Code
- KXF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: 03/28/2013. 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 PREP STICK. THE CUSTOMER STATES THAT THE SPONGE TIP IS COMING OFF OF THE STICK DURING VAGINAL PREP. THE DOCTOR HAD TO REMOVE THE SPONGE USING FORCEPS. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED AND THE CUSTOMER WAS NOT GIVEN ANY MEDICATIONS OR ANTIBIOTICS AS A RESULT OF THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 130031 | STICK SPONGE PVP PAINT | PREP STICK | KXF | COVIDIEN | 41550 | 2EO29 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |