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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 Missing Value Reason (3192)
Event Date 01/10/2017
Event Type  Malfunction  
Manufacturer Narrative

The distributor specified in the declaration the following : " the torn xb c-10 was forwarded so we could examine the tear. The rough edge of the tear demonstrated evidence of excessive force placed on the material. ". Examination of the lot file of the incriminated device reveiled no quality or manufacturing problem.

 
Event Description

The distributor reported that : the surgeon was repairing an umbilical hernia and tried to take an xb c-10 cut down to approximately 7 cm in diameter down a 5mm trocar using a laparoscopic grasper. The grasper/cut down xb c-10 got stuck part way down. Upon removing the grasper/xb c-10, the xb c-10 was torn in half. He requested another xb c-10 and completed the procedure without incident. We were contacted to replace the torn xb c-10 which was done. The torn xb c-10 was forwarded so we could examine the tear. The rough edge of the tear demonstrated evidence of excessive force placed on the material.

 
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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 Key6363593
MDR Text Key68515199
Report Number3006617478-2017-00001
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 02/11/2016,02/23/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/28/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date06/19/2020
Device MODEL NumberSURGIMESH XB
Device Catalogue NumberTINTRAC 10
Device LOT NumberF12007A
Was Device Available For Evaluation? Yes
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 Received01/24/2017
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

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