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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 E1522
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 12/05/2015
Event Type  Injury  
Event Description
The importer reported that : "patient had surgery on (b)(6) 2015 for an incisional hernia repair. 0 ethibond was used for the closing the fascia and securing the surgimesh. A jp drain was also placed. The patient experienced increasing drainage from the drain over the next 2 days. On (b)(6) 2015 the bloody drainage increased and the patient 's hematocrit dropped. The patient was taken back to surgery. The surgeon reported when the incision was reopened and a large clot was evacuated it was discovered that mesh had pulled away from the fascia and there was complete fascia dehiscence. The surgeon also reported that all but a handful of the 0 ethibond sutures on the left side had unraveled despite having 8 knots placed in them at the first.
 
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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 Key5401819
MDR Text Key37233630
Report Number3006617478-2016-00002
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072974
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 01/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/11/2019
Device Model NumberE1522
Device Catalogue NumberE1522
Device Lot NumberF10289A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/07/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2013
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: 02/01/2016 Patient Sequence Number: 1
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