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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN SYMBOTEX MESH 20CM MESH, SURGICAL, POLYMERIC

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COVIDIEN SYMBOTEX MESH 20CM MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number SYM20
Device Problem Material Puncture/Hole (1504)
Patient Problems Pain (1994); Hernia (2240)
Event Date 03/11/2019
Event Type  Injury  
Event Description
Pt had hernia repair with mesh (b)(6) 2017 and was admitted (b)(6) 2019 due to recurrent incisional hernia and pain. He was taken for a laparoscopic repair on (b)(6) 2019 and it was noted during surgery that the mesh was intact circumferentially with "a hole blown right out of the middle" and a significant amount of exudate in the hernia sac and with concern for bacterial translocation. A primary repair of the hernia was performed.
 
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Brand NameSYMBOTEX MESH 20CM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN
MDR Report Key8432789
MDR Text Key139346565
Report NumberMW5085004
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
Type of Report Initial
Report Date 03/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Catalogue NumberSYM20
Device Lot NumberPQG0177X
Was Device Available for Evaluation? No
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/18/2019 Patient Sequence Number: 1
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