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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 PCOPM20
Medical Device Problem Code Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes Failure of Implant (1924); Hernia (2240); Unspecified Tissue Injury (4559)
Date of Event 02/02/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, post-operative laparoscopic hernia repair, the patient initial mesh implanted broke at the center and patient had recurrence of para-stoma hernia.The patient underwent re-operation and new mesh device was used to reinforce the initial mesh.The tissue adhering to the hernia phylum had to be resected and dissected.
 
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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 Key11574356
Report Number9615742-2021-00665
Device Sequence Number17049468
Product Code FTL
UDI-Device Identifier10884521177789
UDI-Public10884521177789
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K081126
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (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) 03/26/2021
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 Date04/30/2013
Device Model NumberPCOPM20
Device Catalogue NumberPCOPM20
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/10/2021
Initial Report FDA Received Date03/26/2021
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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