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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 PCO2015FX
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Numbness (2415); No Code Available (3191); Constipation (3274)
Date of Event 10/01/2016
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, the patient experienced post operative pain.It was stated that the patient had bowel issues with bowel blocking up and a lot of constipation despite plenty of fluid and fiber intake.The patient developed severe gluten intolerance, numbness.It was also stated that the pain varies from stabbing, sharp, dull, forceful like a punch, electric shocked, a deep throbbing ache in and around the hernia repair.
 
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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 Key9728063
Report Number9615742-2020-00378
Device Sequence Number11494977
Product Code FTL
UDI-Device Identifier10884521179752
UDI-Public10884521179752
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K110663
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/19/2020
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 Date04/30/2020
Device Model NumberPCO2015FX
Device Catalogue NumberPCO2015FX
Device Lot NumberPPD0720X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/04/2020
Initial Report FDA Received Date02/19/2020
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 Other;
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