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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 Contamination (1120)
Patient Problem Unspecified Infection (1930)
Event Date 08/16/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
The surgeon implanted a surgimesh wn tealfil-8, plug portion only, to repair the patient's inguinal hernia on (b)(6) 2015. The wn tealfil-8 was taken from a sterile package in the operating field. Antibiotics were initiated for the patient on (b)(6) 2016 due to a developing infection. The surgeon partially removed the wn tealfil-8 plug on (b)(6) 2016. The rest of the wn tealfil-8 plug remained in the patient. This case is one (1) of five (5) removals for infection out of approximately 530 open inguinal repairs (<1% infection rate) 08162016 done by the surgeon using the wn tealfil-8 mesh.
 
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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 Key7325765
MDR Text Key101959180
Report Number3006617478-2018-00004
Device Sequence Number1
Product Code FTM
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
Type of Report Initial
Report Date 03/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/23/2019
Device Model NumberSURGIMESH WN
Device Catalogue NumberTEALFIL-8
Device Lot NumberF09720A
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 Received02/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2014
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: 03/08/2018 Patient Sequence Number: 1
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