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