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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 Loss of or Failure to Bond (1068)
Patient Problems Prolapse (2475); No Code Available (3191)
Event Date 10/16/2018
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, post parastomal hernia wherein sugarbaker technique was used, a reoperation was performed following a reoccurrence of hernia of a patient who used mesh. At that time, there was a round hole of about 5 cm around the center of the center band and the hernia reoccurred. It was confirmed that the mesh was under adhering to the abdominal wall around the hole. The hernia was closed with suture and the operation was completed.

 
Manufacturer Narrative

Evaluation summary: no sample was returned for investigation; however, a photo was provided. The visual examination of the provided picture (video camera) shows a well-integrated mesh placed in the abdominal wall. However due to the picture quality, it is not possible to determine where exactly is located the hole in the mesh (2d-band or 3d-band), if it is a tear or a cut, and if the mesh have been overstretched or not. Without the sample a detailed investigation could not be performed. The root cause could not be determined. As no lot number was provided, a review of the device history record could not be performed. All process and test criteria are verified as complying with qa specifications for all product lots prior release to market. 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 Key8059538
MDR Text Key126888955
Report Number9615742-2018-02539
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,Followup
Report Date 12/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/12/2018
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 Received11/14/2018
Was Device Evaluated By Manufacturer? Yes
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: 11/12/2018 Patient Sequence Number: 1
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