FDA Adverse Event
Malfunction
Summary report: N
CURITY PREP RAZOR COMB/COMB BULK NON ST
MDR report key: 999557
·
Received February 19, 2008
Report
- Report Number
- 1282497-2008-00004
- Event Type
- Malfunction
- Date Received
- February 19, 2008
- Date of Event
- January 1, 2008
- Report Date
- February 6, 2008
- Manufacturer
- AMERICAN SAFETY RAZOR CO
- Product Code
- LWK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
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 PREP RAZOR. THE CUSTOMER STATED THAT A NURSE WAS CUT WHILE REMOVING THE CAP FROM THE RAZOR. THE NURSE REC'D STITCHES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURITY PREP RAZOR COMB/COMB BULK NON ST | PREP RAZOR | LWK | AMERICAN SAFETY RAZOR CO | 139083 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |