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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPIDE MEDICAL SURGIMESH WN MESH, SURGICAL, POLYMERIC

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ASPIDE MEDICAL SURGIMESH WN MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SURGIMESH WN
Device Problem Microbial Contamination of Device (2303)
Patient Problem Seroma (2069)
Event Date 12/12/2017
Event Type  Injury  
Event Description
An open incisional hernia repair was performed on the anterior surface of the patients abdominal on (b)(6) 2017. The surgimesh wn was implanted on the patients midline located on top of fascia. The surgimesh wn was a single use sterile device removed from its sterile packaging in the operating field. A drain was inserted at the end of the procedure and removed on (b)(6) 2017. A seroma was noted to have formed on (b)(6) 2017. The surgeon involved chose to not administer antibiotics and the surgimesh wn was removed on (b)(6) 2017.
 
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Brand NameSURGIMESH WN
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
MDR Report Key7205099
MDR Text Key97716706
Report Number3006617478-2018-00001
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061445
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 01/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/11/2019
Device Model NumberSURGIMESH WN
Device Catalogue NumberT1115-8
Device Lot NumberF1219A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/02/2018
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

Patient Treatment Data
Date Received: 01/19/2018 Patient Sequence Number: 1
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