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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX PCOX 25X20CM X1; PARIETEX MESH
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SOFRADIM PRODUCTION PARIETEX PCOX 25X20CM X1; PARIETEX MESH Back to Search Results
Catalog Number PCO2520X
Device Problem Torn Material (3024)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 05/08/2014
Event Type  malfunction  
Event Description
Procedure: lap ventral hernia ; according to the reporter: the mesh tore on the suture line after it was implanted.Mesh was removed and another piece was implanted.Patient was kept under anesthesia for an extended period of time because of this incident.Hernia defect was finally repaired with an additional piece of mesh.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
PARIETEX PCOX 25X20CM X1
Type of Device
PARIETEX MESH
Manufacturer (Section D)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux F016 00
FR  F01600
Manufacturer (Section G)
SOFRADIM PRODUCTION
116 avenue du formans
trevoux F016 00
FR   F01600
Manufacturer Contact
sharon murphy, qa
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key3924693
MDR Text Key4520447
Report Number9615742-2014-00216
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2018
Device Catalogue NumberPCO2520X
Device Lot NumberPNG0672X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received05/19/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2013
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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