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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Hernia (2240); 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 hernia. It was reported that after implant, the patient experienced abdominal pain, recurrent hernia, and adhesions. Post-operative patient treatment included revision surgery and hernia repair with mesh.
 
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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 Key12675887
MDR Text Key277750324
Report Number9615742-2021-02338
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
Report Date 01/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTECT1510AR
Device Catalogue NumberTECT1510AR
Device Lot NumberSRI0155X
Was Device Available for Evaluation? No
Date Manufacturer Received12/29/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/17/2017
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: 10/21/2021 Patient Sequence Number: 1
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