FDA Adverse Event
Malfunction
Summary report: N
CURITY PREP RAZOR COMB/COMB BULK NON ST
MDR report key: 926538
·
Received October 12, 2007
Report
- Report Number
- 1282497-2007-00032
- Event Type
- Malfunction
- Date Received
- October 12, 2007
- Date of Event
- September 1, 2007
- Report Date
- September 14, 2007
- Manufacturer
- AMERICAN SAFETY RAZOR CO.
- Product Code
- LWK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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 ON 9/14/2007 THAT A CUSTOMER HAD A PROBLEM WITH A RAZOR. THE CUSTOMER REPORTS, THAT AN RN CUT HER THUMB WHILE ATTEMPTING TO REMOVE THE RAZOR COVER. SHE WAS SEEN IN THE EMERGENCY ROOM AND IS OUT OF WORK ON WORKER'S COMPENSATION.
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 |