FDA Adverse Event
Malfunction
Summary report: N
00006 COTTON PREPPING BALL MEDIUM
MDR report key: 1062174
·
Received June 13, 2008
Report
- Report Number
- 1282497-2008-00014
- Event Type
- Malfunction
- Date Received
- June 13, 2008
- Date of Event
- June 4, 2008
- Report Date
- June 5, 2008
- Manufacturer
- AMERICAN FIBER & FINISHING
- Product Code
- FRL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
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 TYCO HEALTHCARE/KENDALL IN 2008 THAT A CUSTOMER HAD A PROBLEM WITH A COTTON BALL. THE CUSTOMER REPORTS THAT A STAFF MEMBER WAS STUCK WITH A SHARP, NEEDLE-LIKE DEVICE FOUND IN THE COTTON BALLS. MEDICAL INTERVENTION WAS REQUIRED, THE EMPLOYEE REQUIRED FOLLOW UP TESTING FOR A POSSIBLE BLOOD AND BODY FLUID EXPOSURE FOR AN UNKNOWN SOURCE AS THE TREATING PROVIDER COULD NOT RULE OUT THE POSSIBILITY OF THE SHARP BEING CONTAMINATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 00006 COTTON PREPPING BALL MEDIUM | COTTON BALL | FRL | AMERICAN FIBER & FINISHING | 2600 | H10926002Z |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |