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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 PCO8VP
Device Problems Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Foreign Body Reaction (1868); Failure of Implant (1924); Hernia (2240); Injury (2348); No Code Available (3191)
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 resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The patient underwent a incisional hernia repair with mesh. Revision surgery 1 years and 2 months post-surgery. The patient experienced multiple surgical revisions, lysis of periumbilical adhesions, abdominal pain, mesh deeply embedded within fragments of yellow-grey fibro fatty soft tissue, additional surgery required to repair hernia defect, lysis of adhesions.
 
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. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. 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. Product was used for therapeutic treatment of an incisional epigastric hernia. It was reported that after implant, the patient experienced abdominal pain, adhesions, mesh deeply embedded within fragments of yellow-grey fibro fatty soft tissue, and recurrence. Post-operative patient treatment included revision surgery, lysis of adhesions, and repair of hernia defect.
 
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. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. (b)(4). 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. Product was used for therapeutic treatment of an incisional epigastric hernia. It was reported that after underlay implant, the patient experienced abdominal pain, adhesions, mesh deeply embedded within fragments of yellow-grey fibro fatty soft tissue, bad allergy reaction to mesh and recurrence. Post-operative patient treatment included revision surgery, laparoscopic lysis of adhesions and repair of hernia defect.
 
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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
MDR Report Key7399071
MDR Text Key104435255
Report Number9615742-2018-00761
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2019
Device Model NumberPCO8VP
Device Catalogue NumberPCO8VP
Device Lot NumberPOE0747
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/05/2018 Patient Sequence Number: 1
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