FDA Adverse Event
Malfunction
Summary report: N
Q-TIPS SWAB STERI TWO'S BULK
MDR report key: 1737727
·
Received June 11, 2010
Report
- Report Number
- 1314412-2010-00003
- Event Type
- Malfunction
- Date Received
- June 11, 2010
- Date of Event
- May 31, 2010
- Report Date
- June 3, 2010
- Manufacturer
- COVIDIEN
- Product Code
- KXG
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2010. 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) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A COTTON TIP APPLICATOR. THE CUSTOMER REPORTED THAT THE COTTON TIP DETACHED FROM THE WOODEN STICK WHILE INSIDE OF A PT'S POST-OPERATIVE WOUND SITE. THE PT REQUIRED EXPLORATORY SURGERY TO LOCATE AND REMOVE THE COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | Q-TIPS SWAB STERI TWO'S BULK | COTTON TIP APPLICATOR | KXG | COVIDIEN | 8884541300 | 1003603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |