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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETEX; MESH, SURGICAL, POLYMERIC
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SOFRADIM PRODUCTION SAS PARIETEX; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO1510FX
Medical Device Problem Code Loss of or Failure to Bond (1068)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/24/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during a laparoscopic intraperitoneal onlay mesh (ipom) procedure, on the abdominal wall, the sutures adhering the mesh broke off in site when it was touched using atraumatic laparoscopic clamps.The mesh was fixed using a tacker.There was no patient injury.
 
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Brand Name
PARIETEX
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR  01600
MDR Report Key9183969
Report Number9615742-2019-03412
Device Sequence Number2811741
Product Code FTL
UDI-Device Identifier10884521179684
UDI-Public10884521179684
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K110663
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/13/2019
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
Operator of Device Health Professional
Device Expiration Date05/31/2023
Device Model NumberPCO1510FX
Device Catalogue NumberPCO1510FX
Device Lot NumberPSF0468M
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/24/2019
Initial Report FDA Received Date10/14/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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