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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPIDE MEDICAL SURGIMESH WN; TEALFIL-8
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ASPIDE MEDICAL SURGIMESH WN; TEALFIL-8 Back to Search Results
Model Number SURGIMESH WN
Device Problem Biocompatibility (2886)
Patient Problem Unspecified Infection (1930)
Event Date 03/02/2017
Event Type  Injury  
Event Description
The surgeon implanted a surgimesh wn tealfil-8 using only the plug portion of the product to repair the patient's inguinal hernia on (b)(6) 2016.The wn tealfil-8 was taken from a sterile package in the operating field.Antibiotics were initiated for the patient on (b)(6) 2017 due to a developing infection.The surgeon removed the mesh on (b)(6) 2017.The surgeon notified the distributor of this event on (b)(6) 2017.This case is one (1) of five (5) removals for infection out of approximately 530 open inguinal repairs done by the surgeon using the wn tealfil-8 mesh.
 
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Brand Name
SURGIMESH WN
Type of Device
TEALFIL-8
Manufacturer (Section D)
ASPIDE MEDICAL
246 allee lavosier
latalaudiere, france 42350
FR  42350
MDR Report Key7183717
MDR Text Key97021734
Report Number3005841068-2017-00006
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
Type of Report Initial
Report Date 01/12/2018,01/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date12/19/2019
Device Model NumberSURGIMESH WN
Device Catalogue NumberTEALFIL-8
Device Lot NumberF11004A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/12/2018
Distributor Facility Aware Date12/18/2017
Event Location Hospital
Date Report to Manufacturer01/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age21 YR
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