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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 Code No Code Available (3191)
Date of Event 10/08/2019
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, post-parastomal hernia surgery, as was noted by computed tomography scan, recurrence was noted from the broken part about six cm in the center of the mesh.Hernia repair was performed by using another mesh without removing the broken mesh.Patient was discharged from the hospital and the progress was under observation.
 
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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 Key9295915
Report Number9615742-2019-03655
Device Sequence Number380742
Product Code FTL
UDI-Device Identifier10884521177758
UDI-Public10884521177758
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K081126
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/08/2019
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 Expiration Date05/31/2018
Device Model NumberPCOPM15
Device Catalogue NumberPCOPM15
Device Lot NumberPNF0306
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/24/2019
Initial Report FDA Received Date11/08/2019
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 Required Intervention;
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