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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETENE PROGRIP RT PPL/PLA 12X8CM; MESH

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SOFRADIM PRODUCTION PARIETENE PROGRIP RT PPL/PLA 12X8CM; MESH Back to Search Results
Model Number PP1208DR
Device Problems Migration or Expulsion of Device (1395); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Code Available (3191)
Event Date 12/03/2007
Event Type  Injury  
Event Description
Procedure: hernia repair according to the reporter, something went wrong during a hernia repair and the patient was re-operated.Another re-operation was performed and a parietene mesh was placed.Later it ruptured and a 4th surgery was performed.During this latest surgery they noticed that the mesh vanished.It was not on the place where it was implanted.The last surgery happened in another hospital.No further patient harm was reported.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
PARIETENE PROGRIP RT PPL/PLA 12X8CM
Type of Device
MESH
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, CT 06473
2034925267
MDR Report Key4619302
MDR Text Key5659474
Report Number9615742-2015-00014
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPP1208DR
Device Catalogue NumberPP1208DR
Device Lot NumberSHC00403
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/27/2015
Initial Date FDA Received03/20/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age37 YR
Patient Weight29
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