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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPIDE MEDICAL SURGIMESH XB TINTRA E-2226

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ASPIDE MEDICAL SURGIMESH XB TINTRA E-2226 Back to Search Results
Model Number XB TINTRA E-2226
Device Problem Device Issue (2379)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 05/17/2016
Event Type  Injury  
Event Description
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 DeviceTINTRA E-2226
Manufacturer (Section D)
ASPIDE MEDICAL
246 allee lavoisier
latalaudiere, france 42350
FR 42350
MDR Report Key5697556
MDR Text Key46502465
Report Number3005841068-2016-00003
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 06/03/2016,06/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/26/2019
Device Model NumberXB TINTRA E-2226
Device Catalogue NumberXB TINTRA E-2226
Device Lot NumberF10267A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/03/2016
Distributor Facility Aware Date05/17/2016
Event Location Hospital
Date Report to Manufacturer06/03/2016
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/03/2016 Patient Sequence Number: 1
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