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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 PCO12X
Device Problems Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Emotional Changes (1831); Fistula (1862); Unspecified Infection (1930); Pain (1994); Distress (2329); Impaired Healing (2378); Fluid Discharge (2686); 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 an incisional hernia. It was reported that after implant, the patient experienced defective device, mental pain, disability, impairment, loss of enjoyment of life, mental anguish, emotional distress, persistent drainage, fistula, open wound, adhesions, mesh bunched up, pain, infections, and bowel problems. Post-operative patient treatment included removal of adhesions, excision of mesh, and debridement of fistula.
 
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 Key14283239
MDR Text Key290793841
Report Number9615742-2022-00422
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521179745
UDI-Public10884521179745
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110815
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 05/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCO12X
Device Catalogue NumberPCO12X
Was Device Available for Evaluation? No
Date Manufacturer Received04/13/2022
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: 05/04/2022 Patient Sequence Number: 1
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