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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 09/04/2017
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 approach, 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
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
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 Key7638025
MDR Text Key112331378
Report Number9615742-2018-01365
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,Followup
Report Date 10/03/2018
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? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Model NumberPCOPM20
Device Catalogue NumberPCOPM20
Device Lot NumberPPH0355X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? No
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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