Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPIDE MEDICAL SURGIMESH WN; TEALFIL-8
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 10/03/2017
Event Type  Injury  
Event Description
The surgeon implanted a surgimesh wn tealfil-8, using the plug portion only, to repair the patient's inguinal hernia on (b)(6) 2015.The wn teafil-8 was removed from sterile packaging in the operating field.Antibiotics were initiated for the patient on 1/26/16 due to a developing infection.The surgeon removed the mesh on (b)(6) 2017.This case is one (1) of five (5) removals for infection out of approximately 530 open inguinal repairs (<1% infection rate) done by the surgeon using the wn tealfil-8 mesh.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SURGIMESH WN
Type of Device
TEALFIL-8
Manufacturer (Section D)
ASPIDE MEDICAL
246 allee lavosier
latalaudiere, france 42350
FR  42350
MDR Report Key7183738
MDR Text Key97057167
Report Number3005841068-2017-00010
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 Date09/13/2019
Device Model NumberSURGIMESH WN
Device Catalogue NumberTEALFIL-8
Device Lot NumberF10300A
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
-
-