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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 PCO3020FX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Pain (1994); Burning Sensation (2146); Hernia (2240); Discomfort (2330); Fluid Discharge (2686); Unspecified Tissue Injury (4559)
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 and incisional hernia. It was reported that after implant, the patient experienced dense adhesions, hernia recurrence, burning sensation, severe and chronic pain and discomfort. Post-operative patient treatment included additional surgery.
 
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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 Key12178669
MDR Text Key261905456
Report Number9615742-2021-01754
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110663
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 07/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2013
Device Model NumberPCO3020FX
Device Catalogue NumberPCO3020FX
Device Lot NumberPLF00627
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2021
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: 07/15/2021 Patient Sequence Number: 1
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