• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYRINGE; SYRINGE, PISTON

  • 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
 

SYRINGE; SYRINGE, PISTON Back to Search Results
Device Problems Defective Device (2588); Mechanical Jam (2983)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Spontaneous communication from the patient who reports that due to a defective whisperject autoinjector device, which jammed, the patient had to waste 2 syringes of glatiramer.She did not miss any doses but is requesting a new whisperject device and replacement of the 2 wasted syringes.There was no adverse event reported.It is unknown if the defective product/device is available for return.No further information was provided.Reported to (b)(6) by pt/caregiver.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYRINGE
Type of Device
SYRINGE, PISTON
MDR Report Key12744906
MDR Text Key280478467
Report NumberMW5105086
Device Sequence Number2
Product Code FMF
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 10/28/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
GLATIRAMER ACETATE (12X1ML)
-
-