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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION PCO VENTRAL PATCH 8C; PARIETEX MESH

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SOFRADIM PRODUCTION PCO VENTRAL PATCH 8C; PARIETEX MESH Back to Search Results
Catalog Number PCO8VP
Device Problems Break (1069); Packaging Problem (3007)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/12/2014
Event Type  malfunction  
Event Description
Procedure: hernia.According to the reporter: surgeon went to open the package and noticed that the mesh was broken.Opened a new package and proceeded with the case.No patient contact.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
PCO VENTRAL PATCH 8C
Type of Device
PARIETEX MESH
Manufacturer (Section D)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux F-01 600
FR  F-01600
Manufacturer (Section G)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux
FR  
Manufacturer Contact
sharon murphy, qa
60 middleton ave
north haven, CT 06473
2034925267
MDR Report Key3938558
MDR Text Key20787982
Report Number9615742-2014-00096
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120506
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2018
Device Catalogue NumberPCO8VP
Device Lot NumberPNI0626
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/18/2014
Initial Date FDA Received03/04/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2013
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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