FDA Adverse Event
Other
Summary report: N
CRANBERRY
MDR report key: 22613
·
Received March 14, 1995
Report
- Report Number
- 1004421-1994-09001
- Event Type
- Other
- Date Received
- March 14, 1995
- Date of Event
- November 16, 1994
- Report Date
- February 16, 1995
- Manufacturer
- CRANBERRY (M) SDN. BHD.
- Product Code
- LYY
- Adverse Event
- Yes
- Report Source
- Distributor report
Narratives
Description of Event or Problem · 1
CRANBERRY BRAND HYPOALLERGENIC LATEX EXAMINATION GLOVES SIZE SMALL AMBIDEXDRIOUS LIGHTLY POWERED, NON STERILE DISPOSABLE GLOVES WERE PLACED ON FRESHLY WASHED HANDS AFTER 10-15 MINUTES, GLOVES WERE REMOVED AND A RED RASH WITH PIMPLY BUMPSOCCURRED ON THE TOP SURFACE OF THE HANDS. ITCHY AND BURNING SENSATION WERE ALSO FELT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRANBERRY | LATEX EXMANIATION GLOVES | LYY | CRANBERRY (M) SDN. BHD. | 3836 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Other |