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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 PCO2520FX
Medical Device Problem Code Material Split, Cut or Torn (4008)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/28/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, on a robotic laparoscopic intraperitoneal onlay mesh (ipom) redo procedure, it was found that the mesh implanted back in (b)(6) 2017 ruptured in the middle.Another device was used to complete the case.There was no patient injury.
 
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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 Key11547925
Report Number9615742-2021-00624
Device Sequence Number14587074
Product Code FTL
UDI-Device Identifier10884521179813
UDI-Public10884521179813
Combination Product (Y/N)N
Initial Reporter CountryBE
PMA/510(K) Number
K110663
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date04/30/2013
Device Model NumberPCO2520FX
Device Catalogue NumberPCO2520FX
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/28/2021
Initial Report FDA Received Date03/22/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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