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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 UNKNOWN PARIETEX PRODUCT
Device Problems Material Erosion (1214); Unintended Movement (3026)
Patient Problems Erosion (1750); Tissue Damage (2104); Tissue Damage (2104); No Code Available (3191)
Event Date 12/07/2011
Event Type  Injury  
Manufacturer Narrative
Occupation: na/other. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during a laparoscopic ventral mesh rectopexy, mesh subsequently eroded into the back of the wall of the vagina. The patient was required further surgery to remove the mesh and repair the vagina.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Occupation: na/other. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during a laparoscopic ventral mesh rectopexy, mesh subsequently eroded into the back of the wall of the vagina. The patient was required further surgery to remove the mesh and repair the vagina.
 
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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
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 Key7756505
MDR Text Key116224759
Report Number9615742-2018-01815
Device Sequence Number0
Product Code FTL
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/03/2018
2 Devices were Involved in the Event: 1   2  
2 Patients were Involved in the Event: 1   2  
Date FDA Received08/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN PARIETEX PRODUCT
Device Catalogue NumberUNKNOWN PARIETEX PRODUCT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
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? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/07/2018 Patient Sequence Number: 0
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