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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 PCOPM15
Device Problem Material Split, Cut or Torn (4008)
Patient Problems Tissue Damage (2104); Prolapse (2475); No Code Available (3191)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, a patient with a parastomal hernia was cured with sugarbaker about 3 years ago experienced a recurrence. When the doctor opened the surgical site, they saw that there was a hole in the middle of the mesh and it had become a hernia orifice. It seemed that the doctor thought keyhole type might have been used. The incarceration was removed in the first revision surgery, but the hernia was incarcerated and reoccurred, so the second revision surgery was performed and at that time the doctor did not use mesh. Reoperation was required due to the issue. The procedure was converted to an open procedure. There was tissue damage.

 
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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 Key8053075
MDR Text Key126600184
Report Number9615742-2018-02524
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK081126
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial
Report Date 11/08/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/08/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPCOPM15
Device Catalogue NumberPCOPM15
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 Received10/11/2018
Was Device Evaluated By Manufacturer? No Answer Provided
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: 11/08/2018 Patient Sequence Number: 1
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