FDA Adverse Event
Injury
Summary report: N
SEMPERCARE NIPFT 103
MDR report key: 1026303
·
Received March 29, 2008
Report
- Report Number
- 1063245-2008-00001
- Event Type
- Injury
- Date Received
- March 29, 2008
- Date of Event
- March 1, 2008
- Report Date
- March 28, 2008
- Manufacturer
- SIAM SEMPERMED CORP., LTD.
- Product Code
- FMC
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
NURSE IN PT CARE AT HOSP, DONNED NITRILE GLOVES AND HAD ALLERGIC REACTION, REQUIRING OVERNIGHT STAY IN ICU.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SEMPERCARE NIPFT 103 | NITRILE EXAMINATION GLOVE | FMC | SIAM SEMPERMED CORP., LTD. | NA | 122007 7043 1730 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Hospitalization |