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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 PCO6VP
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Diarrhea (1811); Emotional Changes (1831); Fatigue (1849); Foreign Body Reaction (1868); Granuloma (1876); Inflammation (1932); Nausea (1970); Pain (1994); Scar Tissue (2060); Discomfort (2330); Injury (2348); Malaise (2359); Sweating (2444); Diaphoresis (2452); Lethargy (2560); Abdominal Distention (2601); Fibrosis (3167); No Code Available (3191); Unspecified Tissue Injury (4559); Decreased Appetite (4569); 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 a recurrent umbilical hernia. It was reported that after implant, the patient experienced dense adhesions of omentum to mesh, inflamed omentum, and pain. Post-operative patient treatment included mesh explant with primary repair of the hernia.
 
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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 Key9315648
MDR Text Key166174237
Report Number9615742-2019-03708
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142908
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 01/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Model NumberPCO6VP
Device Catalogue NumberPCO6VP
Device Lot NumberPOJ0162X
Was Device Available for Evaluation? No
Date Manufacturer Received12/22/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/16/2014
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: 11/13/2019 Patient Sequence Number: 1
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