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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS PARIETENE DS MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PPDS12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Seroma (2069); Swelling (2091); No Known Impact Or Consequence To Patient (2692)
Event Date 06/28/2018
Event Type  malfunction  
Manufacturer Narrative
Occupation: na (other). If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, there was a seroma in the belly button, that commonly develop in the body after surgery.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, following a ventral hernia repair, there was mild swelling in the belly button of the patient. Something that commonly develops in the body after surgery.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, following a ventral hernia repair, there was a seroma in the belly button of the patient. Something that commonly develops in the body after surgery.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePARIETENE DS
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 Key7715510
MDR Text Key115139343
Report Number9615742-2018-01718
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Model NumberPPDS12
Device Catalogue NumberPPDS12
Device Lot NumberRRK1387X
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
Date Device Manufactured02/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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