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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPIDE MEDICAL SURGIMESH SURGIMESH XB

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ASPIDE MEDICAL SURGIMESH SURGIMESH XB Back to Search Results
Model Number TINTRA E-1522
Device Problem Insufficient Information (3190)
Patient Problem Seroma (2069)
Event Date 06/20/2013
Event Type  Injury  
Event Description

The surgeon performed an open recurrent incisional hernia on (b)(6) 2012 using a surgimesh xb e-1522 which went well with no apparent problems. On (b)(6) 2013 notification was received from the operating room director indicating that the surgeon had removed the xb implanted on (b)(6) 2012. In speaking with the surgeon, several attempts to eradicate a post-operative seroma via aspiration and drainage were made without success. Due to this, the decision was made to reoperate. At reoperation, the surgeon found serous fluid around the mesh. As a result, the xb was removed and replaced with a biologic mesh.

 
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Brand NameSURGIMESH
Type of DeviceSURGIMESH XB
Manufacturer (Section D)
ASPIDE MEDICAL
245 altec lavoisier
la taraudiere 4235 0
FR 42350
Manufacturer Contact
245 altec lavoisier
la taraudiere 42350
77531659
MDR Report Key3252701
MDR Text Key3617606
Report Number3005841068-2013-00005
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK072974
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 07/10/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device EXPIRATION Date12/15/2016
Device MODEL NumberTINTRA E-1522
Device Catalogue NumberXB E-1522
Device LOT NumberF06236A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/12/2013
Distributor Facility Aware Date06/20/2013
Event Location Hospital
Date Report TO Manufacturer07/12/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/17/2013 Patient Sequence Number: 1
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