FDA Adverse Event
Malfunction
Summary report: N
DERMACLEAN X-AM POWDER/FREE
MDR report key: 428337
·
Received October 28, 2002
Report
- Report Number
- MW4003347
- Event Type
- Malfunction
- Date Received
- October 28, 2002
- Report Date
- October 19, 2002
- Manufacturer
- ANSELL HEALTHCARE PRODUCTS, INC.
- Product Code
- FMC
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE GLOVES SEPARATE AT THE WRIST AND WHEN PULLING THEM ON THE ACTION CAUSES A TEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DERMACLEAN X-AM POWDER/FREE | EXAMINING GLOVE | FMC | ANSELL HEALTHCARE PRODUCTS, INC. | * | 0107362728 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |