EPIPEN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-06 for EPIPEN manufactured by Dey Pharma Lp.

Event Text Entries

[2328639] Patient prescribed new epipen by (b)(6) hospital, (b)(6), er attending physician on (b)(6) after er treatment for severe anaphylactic shock due to multiple yellow jacket stings received while mowing farm. Severe reaction required double dosing and extended stay in er for observation. Advised to carry epipen in future, use it immediately if stung, and report immediately to er for additional treatment. Patient bought (b)(4) for epipen 0. 3 mg auto injection from (b)(6) pharmacy, (b)(4) on (b)(6) 2011 after leaving er. Device manufactured by (b)(6), meridian medical technologies, (b)(6), wholly-owned subsidiary of (b)(6). Patient stung again on farm, but this time by honey bee, on (b)(6). Immediately tried to use epipen, but device failed to function. Needle could not be exposed from 'orange safety cover. ' hit thigh multiple times, hit epipen on porcelain sink, hit epipen on dashboard of car en route to er. Arrived at er with throat swollen nearly closed, eyes almost closed, difficulty breathing, life threatening situation. Er attending physician wash anded epipen and also could not make it function. Said "this could have cost you your life. " i will investigate and determine how to report. Advised patient to return epipen to (b)(6) pharmacy (b)(6) so they could return to (b)(4) distributors who could return to manufacturer in order to establish chain of evidence, and proper reporting. Issued new prescription for alternate type epipen (generic or one without safety cover that keeps needle from working) but none are available at any of 5 local pharmacies. No options for a mandatory life saving device for those who react to honey bees, wasp, yellow jacket, hornet stings. Urgent review of device malfunction that caused life threatening condition requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5022162
MDR Report Key2243973
Date Received2011-09-06
Date of Report2011-09-06
Date of Event2011-09-01
Date Added to Maude2011-09-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameEPIPEN
Generic NameEPINEPHRINE AUTO INJECTOR 0.3MG
Product CodeKZE
Date Received2011-09-06
Returned To Mfg2011-09-01
Lot Number1GH049
Device Expiration Date2012-09-12
Device AvailabilityR
Device Sequence No1
Device Event Key0
ManufacturerDEY PHARMA LP
Manufacturer AddressNAPA CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2011-09-06

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