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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 PCO2520X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Edema (1820); Erythema (1840); Foreign Body Reaction (1868); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Scarring (2061); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Blood Loss (2597); Fibrosis (3167); 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. The product was used for therapeutic treatment of a hernia. It was reported that after implant, the patient experienced recurrent hernia due to failure of the mesh, small bowel obstruction, dense visceral adhesions of the small bowel to the mesh infection and partial removal of the mesh. Treatment provided for these conditions include removal.
 
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. The product was used for therapeutic treatment of a ventral incisional hernia. It was reported that after implant, the patient experienced recurrent hernia due to failure of the mesh, small bowel obstruction, necrosis, dense visceral adhesions of the small bowel to the mesh, hematoma, open wound, bleeding, and infection. Treatment provided for these conditions include removal, exploratory laparotomy, repair of hernia, repair of enterotomies small bowel, evacuation of hematoma, wound washout and debridement, wound vac, and partial removal of the mesh.
 
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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 Key7970700
MDR Text Key123875662
Report Number9615742-2018-02287
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K110815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup,Followup
Report Date 01/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2018
Device Model NumberPCO2520X
Device Catalogue NumberPCO2520X
Device Lot NumberPNH0288X
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/16/2018 Patient Sequence Number: 1
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