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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 Problem Break (1069)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  malfunction  
Event Description
[pfizer covid 19 vaccine] treatment under emergency use authorization(eua): covid 19 vaccine by pfizer syringe broke and sprayed vaccine in immunizers eyes.
 
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Brand NameSYRINGE
Type of DeviceSYRINGE, PISTON
MDR Report Key11411693
MDR Text Key234928646
Report NumberMW5099759
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 03/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

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