FDA Adverse Event
Other
Summary report: N
UNK
MDR report key: 217956
·
Received April 8, 1999
Report
- Report Number
- 2084395-1999-00019
- Event Type
- Other
- Date Received
- April 8, 1999
- Report Date
- April 7, 1999
- Manufacturer
- SAFESKIN CORP.
- Product Code
- LYY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
ON MARCH 13, 1999, SAFESKIN CORP WAS SERVED WITH THE FOLLOWING LAWSUIT: PLAINTIFF'S CLAIM ALLEGES THE FOLLOWING: LATEX HYPERSENSITIVITY, ASTHMA, RESPIRATORY PROBLEMS, HIVES, DERMATITIS, DIARRHEA, VOMITING, CONFUSION, THROAT SORENESS, FATIGUE, EXTREME DISCOMFORT, DEPRESSION AND EMOTIONAL DISTRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | LATEX GLOVE | LYY | SAFESKIN CORP. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |