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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN VENTRALEX MESH

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COVIDIEN VENTRALEX MESH Back to Search Results
Lot Number PQE0791X
Device Problem Insufficient Information (3190)
Patient Problem Hematoma (1884)
Event Date 05/08/2017
Event Type  Injury  
Event Description

Incarcerated ventral hernia repair with mesh and partial omentectomy in 2016. On (b)(6) 2017, pt returned to surgery for chronic draining sinus of the epigastric hernia repair that developed a postoperative hematoma and required drainage with mesh removal.

 
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Brand NameVENTRALEX MESH
Type of DeviceVENTRALEX MESH
Manufacturer (Section D)
COVIDIEN
MDR Report Key7147553
MDR Text Key95931232
Report NumberMW5074227
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 12/08/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/26/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device LOT NumberPQE0791X
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
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: 12/26/2017 Patient Sequence Number: 1
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