FDA Adverse Event Death Summary report: N

EPIPEN

MDR report key: 342266 · Received July 16, 2001

Report

Report Number
MW1022394
Event Type
Death
Date Received
July 16, 2001
Date of Event
September 4, 2000
Report Date
July 16, 2001
Manufacturer
DEY INC.
Product Code
FMF
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
WI, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

THE DEVICE WAS BOUGHT BY THE RPTR FOR EMERGENCY USE IN THE EVENT THAT RPTR GOT STUNG BY A BEE. ONE DAY RPTR GOT STUNG BY A BEE ABOUT FOUR TIMES. RPTR ATTEMPTED TO INJECT THE DEVICE ON SELF, AND NOTHING HAPPENED. THE EPIPEN FAILED TO INJECT ON TWO ATTEMPTS BY THE RPTR. THE RPTR STATED THAT THEY PASSED OUT AND ACTUALLY DIED BY THE TIME THE AMBULANCE ARRIVED ON THE SCENE. RPTR STATED THEY WERE RESUSCITATED BY THE AMBULANCE STAFF AND THEY TOOK HER TO THE HOSP. THE HOSP TRIED TO INTUBATE RPTR BUT COULDN'T. THEY HAD TO SEND RPTR TO ANOTHER HOSP BY HELICOPTER. RPTR FURTHER STATED THAT ON THE WAY TO THE OTHER HOSP, THEY REPORTEDLY DIED AND HAD TO BE RESUSCITATED AGAIN. RPTR STATED THEY WERE TOTALLY UNCONSCIOUS DURING THIS PHASE UNTIL THE NEXT MORNING WHEN RPTR REGAINED CONSCIOUSNESS. RPTR STATED THAT THEY STAYED IN THE HOSP FOR A TOTAL OF FOUR DAYS. RPTR STATED THAT THE WHOLE INCIDENT HAS CHANGED THEIR LIFE. RPTR STATED THEY LOST VOICE, FACE WAS SWOLLEN, TONGUE WAS INJURED AND SUFFERED BREATHING DIFFICULTIES. RPTR ALSO SAID THAT THE QUALITY OF VOICE HAS BEEN PERMANENTLY CHANGED AND NOW HAS TO USE AN AMPLIFIER WHEN TALKING ON THE PHONE. RPTR ALSO STATED THAT THEY HAVE OTHER DISABILITIES BECAUSE NOW THEY HAVE INTERNAL BLEEDING AND BOTH A MEMORY AND A THINKING IMPAIRMENT AND HAVE TO BE ON DISABILITY THROUGH THE SOCIAL SECURITY ADMINISTRATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
32196 EPIPEN AUTOMATIC SELF INJECTION DEVICE FMF DEY INC. UNK 95P156

Patients

Seq Age Sex Outcome Treatment
1 56 YR Death| S