Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MYLAN PHARMACEUTICALS WHISPERJECT; SYRINGE NEEDLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MYLAN PHARMACEUTICALS WHISPERJECT; SYRINGE NEEDLE Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Fever (1858); Headache (1880); Itching Sensation (1943); Pain (1994); Swelling (2091)
Event Date 02/15/2018
Event Type  Injury  
Event 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
WHISPERJECT
Type of Device
SYRINGE NEEDLE
Manufacturer (Section D)
MYLAN PHARMACEUTICALS
MDR Report Key7302387
MDR Text Key101280940
Report NumberMW5075562
Device Sequence Number3
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 Other Health Care Professional
Type of Report Initial
Report Date 02/26/2018
5 Devices were Involved in the Event: 1   2   3   4   5  
1 Patient was Involved in the Event
Date FDA Received02/27/2018
Is this an Adverse Event Report? Yes
Device Operator No Information
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age52 YR
Patient Weight92
-
-