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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETENE DS; MESH, SURGICAL, POLYMERIC
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SOFRADIM PRODUCTION SAS PARIETENE DS; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PPDS2015
Medical Device Problem Code Material Split, Cut or Torn (4008)
Health Effect - Clinical Code Hernia (2240)
Date of Event 05/12/2020
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 on a hernia procedure, while re-operating it was found out that the mesh fractured in the midline.The bowel was herniating through the midline device fractured and the bowel was densely adherent to the mesh.
 
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Brand Name
PARIETENE DS
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR  01600
MDR Report Key10905014
Report Number9615742-2020-02671
Device Sequence Number16280000
Product Code FTL
UDI-Device Identifier10884521553477
UDI-Public10884521553477
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K163212
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/25/2020
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 Date11/30/2019
Device Model NumberPPDS2015
Device Catalogue NumberPPDS2015
Device Lot NumberRSF1067X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/06/2020
Initial Report FDA Received Date11/25/2020
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;
Patient Weight97
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