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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO2015
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Pannus (1447); Adhesion(s) (1695); Fistula (1862); Foreign Body Reaction (1868); Injury (2348); Weight Changes (2607); Fibrosis (3167); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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 hernia. It was reported that after implant, the patient experienced dense adhesions and fistula. Post-operative patient treatment included small bowel resection.
 
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 dense adhesions, subserosal tissues associated with fibrosis, granulomatous foreign body reaction, weight loss, panniculus, and fistula. Post-operative patient treatment included small bowel re section, abdominal panniculectomy, lap and open ventral hernia repair, separation of components with mobilization of skin flaps with tissue rearrangement, small bowel resection, repair of colotomy, lap to open ventral hernia repair, placement of ventralight mesh, mobilization of skin flaps, tissue arrangement, complex wound closure, mesh explanation, mobilization of tissue flap, complex wound closure and lysis of adhesions relevant tests/laboratory data, including dates: (b)(6) 2014: pathology report- small bowel shows foreign material in subserosal tissues associated with fibrosis and granulomatous foreign body reaction probably representing mesh material.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter: the patient had to have a panniculectomy because fat necrosis had grown onto the mesh and was hurting. The patient has been hospitalized and has had two hernia repairs since then. Both times, additional mesh was installed. The event report type is serious injury and the event outcome is hospitalization.
 
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Brand NameMESH SOFRADIM - PARIETEX¿ 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 avenue
north haven, CT 06473
2034925563
MDR Report Key6637296
MDR Text Key109780648
Report Number9615742-2017-05158
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other,user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 09/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2015
Device Model NumberPCO2015
Device Catalogue NumberPCO2015
Device Lot NumberPKJ08661
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: 06/13/2017 Patient Sequence Number: 1
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