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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 TECT1510AR
Device Problems Loss of or Failure to Bond (1068); Degraded (1153); Migration or Expulsion of Device (1395); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348); 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 a recurrent right inguinal hernia. It was reported that after implant, the patient experienced adhesions, mesh detached, mesh firmly cemented against ligament and cord, and hernia sac protruded through both previous mesh. Post-operative patient treatment included extensive lysis of adhesions and revision 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, CT 80301
3035816943
MDR Report Key9126969
MDR Text Key160300698
Report Number9615742-2019-03194
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982532
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 02/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Model NumberTECT1510AR
Device Catalogue NumberTECT1510AR
Device Lot NumberSPJ0522X
Was Device Available for Evaluation? No
Date Manufacturer Received01/24/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/24/2015
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: 09/26/2019 Patient Sequence Number: 1
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