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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPIDE MEDICAL SURGIMESH XB TINTRA CK-1522

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ASPIDE MEDICAL SURGIMESH XB TINTRA CK-1522 Back to Search Results
Model Number TINTRA CK-1522
Device Problem Contamination (1120)
Patient Problem Post Operative Wound Infection (2446)
Event Date 06/07/2016
Event Type  Injury  
Event Description
On (b)(6) 2016 the patient had a ventral hernia repaired using surgimesh xb ok-1522. Post operatively the patient was complaining of pain. The patient was brought back to the operating room (or) on (b)(6) 2016 for an exploratory surgery. Upon exploration a build up of puss was found in the area of the xb mesh. The doctor involved stated that since the patient was elderly ((b)(6)), obese and diabetic, these conditions probably contributed to the treatment failure. The xb mesh was removed on (b)(6) 2016 and replaced with surgimend biologic mesh.
 
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Brand NameSURGIMESH XB
Type of DeviceTINTRA CK-1522
Manufacturer (Section D)
ASPIDE MEDICAL
246 allee lavoisier
latalaudiere, france 42350
FR 42350
MDR Report Key5710637
MDR Text Key47086882
Report Number3005841068-2016-00004
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 Physician Assistant
Type of Report Initial
Report Date 06/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/30/2016
Device Model NumberTINTRA CK-1522
Device Catalogue NumberTINTRA CK-1522
Device Lot NumberF09927A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/09/2016
Distributor Facility Aware Date06/07/2016
Event Location Hospital
Date Report to Manufacturer06/09/2016
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: 06/09/2016 Patient Sequence Number: 1
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