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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 PCO9F
Device Problems Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Adhesion(s) (1695); Emotional Changes (1831); Fistula (1862); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Perforation (2001); Scar Tissue (2060); Seroma (2069); Hernia (2240); Distress (2329); Depression (2361); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)
Event Type  Injury  
Event Description
The patient's attorney alleged a deficiency against the device. The product was used for therapeutic treatment of ventral hernia. It was reported that after implant, the patient experienced recurrence, pain, scarring, adhesions, infection, abscess, blood loss, intestinal blockage, fistula, hematoma, seroma, perforation, mental pain, disability, depression, psychological stress, loss of enjoyment of life, defective mesh, mesh contraction, and mesh migration. Post-operative patient treatment included revision surgery, mesh revision, removal of mesh, and hospitalization.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key13906213
MDR Text Key288024121
Report Number9615742-2022-00259
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NONE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCO9F
Device Catalogue NumberPCO9F
Device Lot NumberPIJ00232
Was Device Available for Evaluation? No
Date Manufacturer Received03/09/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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: 03/25/2022 Patient Sequence Number: 1
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