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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SANOFI-AVENTIS U.S. LLC SYRINGE SYRINGE, PISTON

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SANOFI-AVENTIS U.S. LLC 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
Indication -atopic dermatitis, unspecified, directions: inject 600mg under the skin on day 1 then 300mg every 2 weeks thereafter. Inbound call from member stated she had a broken syringe of her dupixent. Unspecified defect. Patient was not able to complete her loading dose (missed dose), unknown if adverse event occurred, lot/exp date or if device available for return. Spontaneous call: no further information provided. Reported to (b)(6) by: patient/caregiver.
 
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Brand NameSYRINGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
SANOFI-AVENTIS U.S. LLC
55 corporate drive
bridgewater NJ 08807
MDR Report Key11568652
MDR Text Key242481916
Report NumberMW5100259
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2021
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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