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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYRINGE SYRINGE, PISTON

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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.
 
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Brand NameSYRINGE
Type of DeviceSYRINGE, 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
3 Devices were Involved in the Event: 1   2   3  
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
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/02/2021 Patient Sequence Number: 1
Treatment
GLATIRAMER ACETATE (12X1ML)
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