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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
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Pain (1994)
Date of Event 06/15/2016
Type of Reportable Event Serious Injury
Event or Problem Description
The distributor reported that : "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
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ASPIDE MEDICAL
246 allee lavoisier
la talaudiere, 42350
FR  42350
MDR Report Key5843356
Report Number3006617478-2016-00008
Device Sequence Number6123
Product Code FTL
UDI-Device Identifier03700296900844
UDI-Public03700296900844
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K061445
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2016
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other Caregivers
Type of Report Initial
Report Date (Section B) 02/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Other Caregivers
Device Expiration Date05/31/2018
Device Model NumberSURGIMESH WN
Device Catalogue NumberTEALFIL-8 PLUG AND PATCH
Device Lot NumberF08351A
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/25/2016
Initial Report FDA Received Date08/03/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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