FDA Adverse Event
Other
Summary report: N
LATEX FREE STRETCH TOURNIQUET
MDR report key: 666537
·
Received January 20, 2006
Report
- Report Number
- 1519375-2006-00001
- Event Type
- Other
- Date Received
- January 20, 2006
- Date of Event
- December 14, 2005
- Report Date
- January 20, 2006
- Manufacturer
- BD
- Product Code
- GAX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORT OF ONE (1) EMPLOYEE HAVING A REACTION WITH THE TOURNIQUET. SHE HAD ITCHY EYES, HAND AND ARMS. SHE DOES HAVE A HISTORY OF SKIN PROBLEMS AND IS TREATED BY A DERMATOLOGIST. CURRENTLY TAKING OVER THE COUNTER ANTIHISTAMINES. STATED THAT THE AFFECTED EMPLOYEE MAY BE ALLERGIC TO THE VANILLA FRAGRANCE ON THE TOURNIQUET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LATEX FREE STRETCH TOURNIQUET | TOURNIQUET | GAX | BD | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |