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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 PCO2H3
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Tissue Damage (2104); Foreign Body In Patient (2687); No Code Available (3191)
Event Date 01/30/2019
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, it occurred after surgery of laparoscopic repair of esophageal hiatus hernia, the patient complained of food choke. When they checked with the endoscope, a foreign material considered as the mesh was found in the esophagus. Patient underwent re-operation with general anesthesia to remove the mesh. They used forceps and the endoscope to remove the foreign material to outside of the body. The foreign material was the mesh with hernia stapler used for fixing were also removed. A part of the foreign material which was thought to be the mesh fragment could not be removed, but there was no problem at intraoperative contrast, the operation was directly completed. The part fell into the patient's cavity and was retrieved. There was tissue damage.
 
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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 Key8373978
MDR Text Key137265253
Report Number9615742-2019-00382
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521178465
UDI-Public10884521178465
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K040998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/30/2016
Device Model NumberPCO2H3
Device Catalogue NumberPCO2H3
Device Lot NumberPLG00434
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2011
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: 02/27/2019 Patient Sequence Number: 1
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