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U.S. Department of Health and Human Services

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

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ASPIDE MEDICAL SURGIMESH XB TINTRA E-1522 Back to Search Results
Model Number SURGIMESH XB
Device Problem Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Date 03/17/2016
Event Type  Injury  
Event Description
Pt had a history of (b)(6) infection(s). Following the initial procedure on (b)(6) 2015, on (b)(6) 2015 the pt was treated for a wound infection with debridement and wound irrigation. Despite this the infection did not resolve but went deeper to involve the xb e-1522. The surgeon brought the pt back to the operating room on (b)(6) 2016 to do further debridement and irrigation choosing to also remove the xb e-1522. It is unk whether or not the surgeon used another surgical mesh or a primary approach to repair the pt hernia. The pt was recovered uneventfully. Mfr ref #3006617478-2016-00003.
 
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Brand NameSURGIMESH XB
Type of DeviceTINTRA E-1522
Manufacturer (Section D)
ASPIDE MEDICAL
246 allee lavoisier
latalaudiere 42350 , FR
FR 42350, FR
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 Key5574316
MDR Text Key42614249
Report Number3005841068-2016-00002
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 03/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date05/17/2019
Device Model NumberSURGIMESH XB
Device Catalogue NumberTINTRA E-1522
Device Lot NumberF09568A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/28/2016
Distributor Facility Aware Date03/17/2016
Event Location Hospital
Date Report to Manufacturer03/28/2016
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: 04/11/2016 Patient Sequence Number: 1
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