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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS PARIETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCOPM15
Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Internal Organ Perforation (1987); Renal Failure (2041); Seroma (2069); Hernia (2240); Peritonitis (2252); Injury (2348); Ascites (2596); No Code Available (3191)
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. 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 an incisional hernia. It was reported that after implant, the patient experienced extensive adhesions, recurrence, bowel incarceration, seroma and perforation in the conduit with urinoma. Post-operative patient treatment included lysis of adhesions, explant of previous mesh and repair of hernia with new mesh.
 
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
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 herniorrhaphy incisional laparoscopic ro. He had revision surgery 2 days post-surgery. The patient experienced surgical revision, extensive adhesions, perforation in the conduit with urinoma.
 
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Brand NamePARIETEX
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
MDR Report Key7171481
MDR Text Key280476566
Report Number9615742-2018-00046
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521177758
UDI-Public10884521177758
Combination Product (y/n)N
PMA/PMN Number
K081126
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup
Report Date 12/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2017
Device Model NumberPCOPM15
Device Catalogue NumberPCOPM15
Device Lot NumberPMK00297
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/08/2018 Patient Sequence Number: 1
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