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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 PCO2H4
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Tissue Damage (2104); Vomiting (2144); Perforation of Esophagus (2399); No Code Available (3191)
Event Date 04/17/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, four years after a nissen fundoplication on hiatal hernia, the patient returned at the hospital throwing up and with pain. The patient's esophagus was perforated which required an exploratory laparotomy, intestinal resection, and removal of the mesh. The surgical time was extended by 30 minutes or more due to the product problem, an extended incision by more than 1 inch or 2. 54cm and tissue damage. The event also lead to extended patient hospitalization.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 ave.
north haven, CT 06473
2034925563
MDR Report Key7699573
MDR Text Key114354307
Report Number9615742-2018-01610
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521178472
UDI-Public10884521178472
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K040998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCO2H4
Device Catalogue NumberPCO2H4
Device Lot NumberPMI00648
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
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: 07/18/2018 Patient Sequence Number: 1
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