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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO12X
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)
Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Internal Organ Perforation (1987); Pain (1994); Swelling (2091); Hernia (2240); Injury (2348); Ambulation Difficulties (2544); Abdominal Distention (2601); No Code Available (3191)
Event Type  Death  
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 ventral hernia. It was reported that after a procedure where this device was implanted, the patient experienced recurrent incisional hernia, stomach pain, swelling, intestinal protrusion, difficulty walking, continuous digestive problems, perforation of tissue/organs, adherence to tissue/organs, infection, nerve damage, subsequent surgeries and other complications. Treatment and potentially related procedures include additional surgery.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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 ventral hernia. It was reported that after a procedure where this device was implanted, the patient experienced recurrent incisional hernia, stomach pain, swelling, intestinal protrusion, difficulty walking, continuous digestive problems, perforation of tissue and/or organs, adherence to tissue/organs, infection, and nerve damage. Treatment for these issues included subsequent surgeries. Information received indicates the patient is deceased. No information was provided regarding the circumstances of expiration or any association with this device.

 
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Brand NameMESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH
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 Key7695583
MDR Text Key114220075
Report Number9615742-2018-01607
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK110815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2019
Device MODEL NumberPCO12X
Device Catalogue NumberPCO12X
Device LOT NumberPOJ0410X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/21/2014
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: 07/17/2018 Patient Sequence Number: 1
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