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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETEX; MESH, SURGICAL, POLYMERIC
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SOFRADIM PRODUCTION SAS PARIETEX; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCOPM15
Medical Device Problem Code Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes Failure of Implant (1924); Hernia (2240); Prolapse (2475); No Code Available (3191); No Code Available (3191)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, after a laparoscopic parastomal hernia repair, the mesh developed a central hole and a hernia occurred through it.A new mesh was implanted to repair the hernia through a second operation.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
PARIETEX
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR  01600
MDR Report Key7704315
Report Number9615742-2018-01644
Device Sequence Number16326642
Product Code FTL
UDI-Device Identifier10884521177758
UDI-Public10884521177758
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K081126
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 10/02/2018
1 Device was Involved in the Event
2 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberPCOPM15
Device Catalogue NumberPCOPM15
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/27/2018
Supplement Date Received by Manufacturer08/08/2018
Initial Report FDA Received Date07/19/2018
Supplement Report FDA Received Date10/02/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number0
Outcome Attributed to Adverse Event Required Intervention;
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