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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 PCO8OSX
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Erosion (1750); Purulent Discharge (1812); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Seroma (2069); Hernia (2240); Obstruction/Occlusion (2422); Ascites (2596); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of incisional hernia. It was reported that after implant, the patient experienced pain, hernia recurrence, mesh migration, seroma, infection, small bowel obstruction, fluid filled cavity with appearance of purulence, fibroadipose tissue, inflammation, foreign body giant cells, foamy histiocytes, old scar, and adhesions. Post-operative patient treatment included revision surgery, ng tube placed, lysis of adhesions, and mesh removal.
 
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Brand NamePARIETEX
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer Contact
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key12652696
MDR Text Key277155909
Report Number9615742-2021-02326
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110816
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Model NumberPCO8OSX
Device Catalogue NumberPCO8OSX
Device Lot NumberPOG0724X
Was Device Available for Evaluation? No
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/30/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/18/2021 Patient Sequence Number: 1
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