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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 PCOPM20
Device Problem Torn Material (3024)
Patient Problems Tissue Damage (2104); Obstruction/Occlusion (2422); No Code Available (3191)
Event Date 12/04/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter,following a laparoscopic repair of a parastomal hernia procedure using a modified sugarbaker operative app roach, the mesh was damaged. The surgeon observed a fracture of the mesh corresponding to the translucent stripe, where this originally covered the hernia defect. There was tissue damage and the patient experienced bowel obstruction as a result of the product problem. The surgical time was extended 30 minutes or more and the event also resulted to an extended patient hospital stay. The patient underwent reoperation for parastomal hernia to resolve the issue and to prevent permanent impairment.
 
Manufacturer Narrative
Evaluation summary: the visual examination of the provided picture shows that, a hole is visible in the middle of the mesh. Tackers are placed well, the distance from the edge of the mesh was found conform. The bowel is passing through the middle of the mesh by the hole. A review of the device history record has been performed. No failure or non-conformance (ncr) that may relate to the reported conditions has been noted. The report has been added to our product complaints database which is monitored for similar occurrences. Based on our investigation and a complaint history review, the manufacture of the device is not suspected. There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend. No immediate action required. If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePARIETEX
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer Contact
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key7637652
MDR Text Key112314304
Report Number9615742-2018-01364
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K081126
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Model NumberPCOPM20
Device Catalogue NumberPCOPM20
Device Lot NumberPPI0631X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/26/2018 Patient Sequence Number: 1
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