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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION PCO VENTRAL PATCH 4C MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION PCO VENTRAL PATCH 4C MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO4VP
Device Problems Failure To Adhere Or Bond (1031); Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
According to the reporter, during an umbilical hernia repair one corner of the mesh would not deploy, a patch was folding perpendicular to the break in the expanders which caused it not to deploy properly.
 
Manufacturer Narrative
Based on review of the file, this report was updated from a malfunction to a non-reportable event.
 
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Brand NamePCO VENTRAL PATCH 4C
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FR
Manufacturer (Section G)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FR
Manufacturer Contact
sharon murphy
60 middletown ave
north haven 
MDR Report Key5998096
MDR Text Key56450872
Report Number9615742-2016-00133
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 company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCO4VP
Device Catalogue NumberPCO4VP
Device Lot NumberPQD0077X
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 Received09/09/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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