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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEVA PHARMACEUTICALS USA INTRODUCER, SYRINGE NEEDLE; EPINEPHRINE AUTO INJECTOR

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TEVA PHARMACEUTICALS USA INTRODUCER, SYRINGE NEEDLE; EPINEPHRINE AUTO INJECTOR Back to Search Results
Lot Number 007G18AA
Device Problem Failure to Deliver (2338)
Patient Problem Missed Dose (2561)
Event Date 07/02/2020
Event Type  Injury  
Event Description
On july 2nd reporter had an anaphylactic reaction to a medication and tried using her epinephrine pen but the auto injector failed.
 
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Brand Name
INTRODUCER, SYRINGE NEEDLE
Type of Device
EPINEPHRINE AUTO INJECTOR
Manufacturer (Section D)
TEVA PHARMACEUTICALS USA
MDR Report Key10326516
MDR Text Key200809065
Report NumberMW5095738
Device Sequence Number1
Product Code KZH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Lot Number007G18AA
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/24/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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