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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 Adhesion(s) (1695); Pain (1994); Tissue Damage (2104); Hernia (2240); Fibrosis (3167); No Code Available (3191)
Date of Event 02/06/2019
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, during a laparoscopic hernia procedure, only the sides of the mesh was left.The midline of the mesh was gone and the intestines had adhere to it.Re surgery was done to repair the hernia recurrence and to free the adhesions.There was tissue damage of adhesions and fibrotic tissue.The patient was hospitalized.The surgical time was extended by three to five hours.The patient had to undergo surgery after this operation also because of pain occurring because of adhesions once again.
 
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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 Key8447973
Report Number9615742-2019-00636
Device Sequence Number19542889
Product Code FTL
UDI-Device Identifier10884521177758
UDI-Public10884521177758
Combination Product (Y/N)N
Initial Reporter CountryNO
PMA/510(K) Number
K081126
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/25/2019
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? Yes
Operator of Device Health Professional
Device Model NumberPCOPM15
Device Catalogue NumberPCOPM15
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/01/2019
Initial Report FDA Received Date03/25/2019
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 Hospitalization; Required Intervention;
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