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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 PCO2520X
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Pain (1994); Seroma (2069); Hernia (2240); Obstruction/Occlusion (2422); Ascites (2596); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
Concomitant product: abstack15 abs fixation device 15 tacks (lot # n2oc437x), abstack15 abs fixation device 15 tacks (lot # n2f0056x). 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 ventral hernia. It was reported that after the implant, the patient experienced adhesions, seroma, mesh erosion, abscess, fluid collection, and hernia recurrence. Post-operative patient treatment included hernia repair with mesh, drainage of seroma, removal of mesh, diagnostic laparoscopy, mesh fenestrated to allow for dissipation of fluid, and lysis of adhesions.
 
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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 Key12029281
MDR Text Key257391847
Report Number9615742-2021-01542
Device Sequence Number1
Product Code FTL
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
Type of Report Initial,Followup
Report Date 01/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/30/2013
Device Model NumberPCO2520X
Device Catalogue NumberPCO2520X
Device Lot NumberPLK00145
Was Device Available for Evaluation? No
Date Manufacturer Received01/12/2022
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: 06/18/2021 Patient Sequence Number: 1
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