FDA Adverse Event
Injury
Summary report: N
*
MDR report key: 208348
·
Received February 1, 1999
Report
- Report Number
- 2126208-1999-00001
- Event Type
- Injury
- Date Received
- February 1, 1999
- Date of Event
- August 24, 1998
- Report Date
- January 13, 1999
- Manufacturer
- UNK
- Product Code
- LYY
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
AN EMPLOYEE AT A FACILITY HAD BEEN EXPERIENCING ALLERGIC SYMPTOMS (RUNNY NOSE, SNEEZING) FOR QUITE SOME TIME. THE SYMPTOMS GOT PROGRESSIVELY WORSE. ON 8/24/1998 SHE EXPERIENCED A SEVERE ALLERGIC REACTION RESULTING IN PULMONARY EDEMA. CO-WORKERS WERE AFRAID SHE WAS HAVING A HEART ATTACK AND CALLED AN AMBULANCE. THE EMPLOYEE WAS HOSPITALIZED FOR 9 DAYS. IT WAS ULTIMATELY DETERMINED THAT SHE WAS ALLERGIC NOT TO THE LATEX BUT TO THE POWDER USED IN THE GLOVES. RED LINE MEDICAL SUPPLY, INC. WAS NOTIFIED OF THIS INCIDENT ON 12/9/1998.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | POWDERED LATEX GLOVES | LYY | UNK | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Hospitalization| R |