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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPIDE MEDICAL SURGIMESH WN; TEALFIL-8 PLUG AND PATCH
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ASPIDE MEDICAL SURGIMESH WN; TEALFIL-8 PLUG AND PATCH Back to Search Results
Model Number TEALFIL-8 PLUG AND PATCH
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Pain (1994)
Event Date 06/15/2016
Event Type  Injury  
Event Description
Patient had a rih repair performed.Four months later when pulling up carpeting felt the area around the original surgery site give way and thereafter was painful.The patient sought treatment about a year later from doctor to relieve the pain.At exploration only the plug portion of the wn tealfil-8 hernia mesh was found healed to the genital and femoral branches of the genitofemoral nerve.No hernia defect was found and no other mesh (the patch portion of the wn tealfil-8) was identified upon further exploration.The patient recovered uneventfully and was discharged.
 
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Brand Name
SURGIMESH WN
Type of Device
TEALFIL-8 PLUG AND PATCH
Manufacturer (Section D)
ASPIDE MEDICAL
246 allee lavoisier
latalaudiere, france 42350
FR  42350
MDR Report Key5776395
MDR Text Key48996230
Report Number3005841068-2016-00005
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 Other Caregivers
Type of Report Initial
Report Date 07/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date05/31/2018
Device Model NumberTEALFIL-8 PLUG AND PATCH
Device Catalogue NumberTEALFIL PLUG AND PATCH
Device Lot NumberF08351A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/05/2016
Distributor Facility Aware Date06/15/2016
Event Location Hospital
Date Report to Manufacturer07/05/2016
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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