FDA Adverse Event
Other
Summary report: N
STRETCH LATEX FREE TOURNIQUET
MDR report key: 1120706
·
Received August 14, 2008
Report
- Report Number
- 1519375-2008-00001
- Event Type
- Other
- Date Received
- August 14, 2008
- Date of Event
- August 5, 2008
- Report Date
- August 14, 2008
- Manufacturer
- HYGENIC CORP.
- Product Code
- GAX
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
HCW REPORTED SOME SORT OF AN ALLERGIC REACTION OCCURRED AT THE SITE WHERE THE TOURNIQUET WAS APPLIED. THE REACTION CREATED A WHEAL AROUND THE PT'S ARM. THE PT WAS ADMINISTERED BENADRYL AND RESPONDED FAVORABLY TO THE MEDICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRETCH LATEX FREE TOURNIQUET | TOURNIQUET | GAX | HYGENIC CORP. | NA | 8B001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |