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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO15FX
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Code Available (3191)
Event Date 05/15/2018
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, post operatively, on a laparoscopic umbilical hernia, upon implantation, the mesh was folded at the expanders junction on fascial side against fascial side, and the violet expanders were broken. The wound was closed after the procedure by suturing and there were twenty six fixation points applied. The surgical time was extended by thirty minutes or more due to the product problem and re operation was needed. The incision was extended more than 1 inch. The event lead to or extended the patient's hospitalization for five days.

 
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Brand NameMESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH
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 Key7577849
MDR Text Key110349393
Report Number9615742-2018-01240
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK110663
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPCO15FX
Device Catalogue NumberPCO15FX
Device LOT NumberPSC0176X
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/27/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/15/2018
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: 06/07/2018 Patient Sequence Number: 1
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