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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN PARIETEX PRODUCT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Burning Sensation (2146); Hernia (2240); Injury (2348); Abdominal Distention (2601)
Event Type  Injury  
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. 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 laparoscopic repair of bilateral complex inguinal hernia. It was reported that after implant, the patient experienced recurrence, bulging, pain, burning, and stabbing sensation. Post-operative patient treatment included revision surgeries where abdominal wall was reinforced with overlapping mesh implants.
 
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Brand NameUNKNOWN PARIETEX PRODUCT
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
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key9313962
MDR Text Key166140887
Report Number9615742-2019-03670
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
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 11/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN PARIETEX PRODUCT
Device Catalogue NumberUNKNOWN PARIETEX PRODUCT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
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: 11/13/2019 Patient Sequence Number: 1
Treatment
UNKABSTACK
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