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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MYLAN PHARMACEUTICALS WHISPERJECT; SYRINGE NEEDLE
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MYLAN PHARMACEUTICALS WHISPERJECT; SYRINGE NEEDLE Back to Search Results
Health Effect - Clinical Codes Fever (1858); Headache (1880); Itching Sensation (1943); Pain (1994); Swelling (2091)
Date of Event 02/15/2018
Type of Reportable Event Serious Injury
Event or Problem Description
On (b)(6) 2018, injected with the whisper ject into right thigh and he experienced thumb needle pain and itching in his right trunk area.(b)(6) 2018, injected into left thigh and woke up the next morning with a headache and also woke up on monday with a fever.On (b)(6) 2018, injected into stomach, the whisper ject malfunctioned and he had to waste that dose due to the button not working.He re-injected and worked that time.On (b)(6) 2018, injected into right thigh and got a 50 cent piece sized welt where the injection was made.(b)(6) 2018, injected into left thigh and experienced the same welt, and itching in the trunk area.Pt has been on brand copaxone for years and never had an issue.Pt also states that the whisper ject, it is not easy to use and a lot harder to inject with.He never had an issue with the copaxone and injector.
 
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Brand Name
WHISPERJECT
Common Device Name
SYRINGE NEEDLE
Manufacturer (Section D)
MYLAN PHARMACEUTICALS
MDR Report Key7302387
Report NumberMW5075562
Device Sequence Number1272375
Product Code KZH
Combination Product (Y/N)N
Initial Reporter StateMT
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 02/26/2018
5 Devices were Involved in the Event: 1   2   3   4   5  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device No Information
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date02/27/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age52 YR
Patient Weight92
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