FDA Adverse Event
Malfunction
Summary report: N
CURITY PREP RAZOR COMB/COMB BULK NON ST
MDR report key: 920635
·
Received October 1, 2007
Report
- Report Number
- 1282497-2007-00031
- Event Type
- Malfunction
- Date Received
- October 1, 2007
- Report Date
- September 5, 2007
- Manufacturer
- AMERICAN SAFETY RAZOR CO
- Product Code
- LWK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
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 THAT A CUSTOMER HAD A PROBLEM WITH A PREP RAZOR. THE CUSTOMER STATED THAT A NURSE RECEIVED A CUT WHEN OPENING THIS PRODUCT. THE NURSE HAD TO GET 8 STITCHES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURITY PREP RAZOR COMB/COMB BULK NON ST | RAZOR | LWK | AMERICAN SAFETY RAZOR CO | 139083 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |