FDA Adverse Event
Other
Summary report: N
DERMA PRENE ISOTOUCH MICRO WHITE
MDR report key: 2413010
·
Received January 10, 2012
Report
- Report Number
- 1019632-2012-00002
- Event Type
- Other
- Date Received
- January 10, 2012
- Report Date
- January 10, 2012
- Manufacturer
- ANSELL LANKA (PVT) LTD.
- Product Code
- LZC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER STATES THAT THE EMPLOYEE IS ALLERGIC TO LATEX AND USED THE DERMA PRENE ISOTOUCH WHITE GLOVE, HOWEVER INSIDE WAS A LATEX GLOVE. THE EMPLOYEE WENT INTO A 'ANAPHYLACTIC SHOCK' AS A RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DERMA PRENE ISOTOUCH MICRO WHITE | SYNTHETIC SURGICAL GLOVE | LZC | ANSELL LANKA (PVT) LTD. | 1106006605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |