FDA Adverse Event
Other
Summary report: N
90017966 COTTON TIPPED APPLICATOR, 6
MDR report key: 2745134
·
Received September 7, 2012
Report
- Report Number
- 1282497-2012-00023
- Event Type
- Other
- Date Received
- September 7, 2012
- Date of Event
- August 1, 2012
- Report Date
- August 8, 2012
- Manufacturer
- CITMED CORPORATION
- Product Code
- KXG
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2012. 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) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A COTTON TIPPED APPLICATOR. THE CUSTOMER REPORTS ONE COTTON TIP FELL OFF AND REMAINED IN THE PATIENT DURING A PAP SMEAR PROCEDURE. FORCEPS WERE USED TO REMOVE THE COTTON TIP FROM THE PATIENT. CUSTOMER REPORTS THAT THE DIAMETER OF SOME OF THE STICKS APPEAR TO BE THINNER AND WEAKER IN STRENGTH THAN OTHERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 90017966 COTTON TIPPED APPLICATOR, 6 | COTTON TIPPED APPLICATOR | KXG | CITMED CORPORATION | 8884540500 | (1) 1069439313394 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |