MAUDE Adverse Event Report: MYLAN EPIPEN; INTRODUCEDR, SYRINGE, NEEDLE

Lot Number 7FM774

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Loss of consciousness (2418)

Event Date 03/11/2018

Event Type  malfunction  

Event Description

The caller was having an anaphylaxis reaction and used an epipen that did not administer the medication effectively.Caller also reported that the medication was not effective in relieving her symptoms.She was almost becoming unconscious and her husband used a second epipen which was effective.This is the second epipen from the same package that has failed.

• Brand Name: EPIPEN
• Type of Device: INTRODUCEDR, SYRINGE, NEEDLE
• Manufacturer (Section D): MYLAN
• MDR Report Key: 7344765
• MDR Text Key: 102833649
• Report Number: MW5075911
• Device Sequence Number: 1
• Product Code: KZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/15/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/01/2019
• Device Lot Number: 7FM774
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 67