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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGEN STRATIS MESH

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ALLERGEN STRATIS MESH Back to Search Results
Device Problem Hole In Material (1293)
Patient Problems Erythema (1840); Fever (1858)
Event Date 11/25/2015
Event Type  Injury  
Event Description
Redness, fever, mesh stratis used in breast reconstruction, then hole appeared in implants, and multiple surgeries through (b)(6) 2016.
 
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Brand NameSTRATIS MESH
Type of DeviceSTRATIS MESH
Manufacturer (Section D)
ALLERGEN
MDR Report Key5690697
MDR Text Key46363613
Report NumberMW5062537
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/25/2016 Patient Sequence Number: 1
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