FDA Adverse Event
Malfunction
Summary report: N
CURITY PREP RAZOR COMB/COMB BULK NON ST
MDR report key: 1038576
·
Received May 3, 2008
Report
- Report Number
- 1282497-2008-00012
- Event Type
- Malfunction
- Date Received
- May 3, 2008
- Date of Event
- March 18, 2008
- Report Date
- April 16, 2008
- Manufacturer
- AMERICAN SAFETY RAZOR CO
- Product Code
- LWK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE 05/01/2008. 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 CONSUMER HAD A PROBLEM WITH A PREP RAZOR. THE CUSTOMER REPORTS THAT A NURSE CUT HER LEFT THUMB WHILE PREPPING A PT. THE NURSE CUT HERSELF BY TRYING TO REMOVE THE CAP FROM THE RAZOR (NON CONTAMINATED). THE RAZOR WAS GRABBED FROM THE TOP AND USED SOME FORCE TO REMOVE THE CAP. THE NURSE REQUIRED 5 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 |