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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPIDE MEDICAL SURGIMESH XB MESH, SURGICAL, POLYMERIC

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ASPIDE MEDICAL SURGIMESH XB MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SURGIMESH XB
Device Problem Device Issue (2379)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 05/17/2016
Event Type  Injury  
Manufacturer Narrative

The physician specified in the declaration the following : "the situation was not related to the performance of the xb e-2226 but rather the patients health status which includes vascular disease".

 
Event Description

The distributor reported that : "on (b)(6) 2015 the patient received a surgimesh xb e-2226 to repair a ventral hernia. On (b)(6) 2015 the patient was brought back for an exploratory surgery to debride some tissue in the area of the hernia repair. On (b)(6) 2016 the patient was again brought back as the xb e-2226 was "bunched up" in an area. The xb e-2226 was removed and in the area where it had been the abdominal wall was solidly healed with no more hernia defect showing. The patient was closed and healed uneventfully. The surgeon stated that the situation was not related to the performance of the xb e-2226 but rather the patients health status which includes vascular disease. ".

 
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Brand NameSURGIMESH XB
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ASPIDE MEDICAL
246 allee lavoisier
la talaudiere, 42350
FR 42350
Manufacturer (Section G)
ASPIDE MEDICAL
246 allee lavoisier
la talaudiere, 42350
FR 42350
Manufacturer Contact
sid ahmed tadjer
246 allee lavoisier
la talaudiere, 42350
FR   42350
77531659
MDR Report Key5747549
MDR Text Key48092801
Report Number3006617478-2016-00006
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK120025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial
Report Date 02/11/2016,06/23/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/24/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date09/26/2019
Device MODEL NumberSURGIMESH XB
Device Catalogue NumberXB TINTRA E2226
Device LOT Number10267A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/11/2016
Event Location No Information
Date Report TO Manufacturer04/25/2016
Date Manufacturer Received06/09/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/30/2014
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: 06/24/2016 Patient Sequence Number: 1
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