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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPIDE MEDICAL SURGIMESH XB TINTRA E1522

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ASPIDE MEDICAL SURGIMESH XB TINTRA E1522 Back to Search Results
Model Number TINTRA E1522
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 12/05/2015
Event Type  Injury  
Event Description
The xb mesh was used in an open repair of a ventral hernia on (b)(6) 2015. The patient experienced coughing postoperatively, felt a "pop" and demonstrated prolonged bloody drainage through an installed drain. After 2 days the surgeon chose to bring the patient back to the or to investigate the situation. Upon investigating the surgeon found a largo clot and the repair disrupted laterally with the suture line disrupted. The surgeon chose to remove the xb mesh and replace it with another synthetic mesh. The removed xb mesh showed no abnormalities.
 
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Brand NameSURGIMESH XB
Type of DeviceTINTRA E1522
Manufacturer (Section D)
ASPIDE MEDICAL
246 allee lavoisier
latalaudiere 42350
FR 42350
Manufacturer (Section G)
BG MEDICAL LLC
20925 pheasant trail
suite 100
deer park IL 60010
Manufacturer Contact
20925 pheasant trail
suite 100
deer park, IL 60010
MDR Report Key5366398
MDR Text Key35968019
Report Number3005841068-2015-00014
Device Sequence Number1
Product Code FTM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/08/2016,01/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/11/2019
Device Model NumberTINTRA E1522
Device Catalogue NumberE1522
Device Lot NumberF10289A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/08/2016
Distributor Facility Aware Date12/11/2015
Event Location Hospital
Date Report to Manufacturer01/08/2016
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/06/2016 Patient Sequence Number: 1
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