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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS SURGIPRO MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS SURGIPRO MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN SURGIPRO MESH
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Exsanguination (1841); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); Blood Loss (2597); No Code Available (3191)
Event Date 01/07/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4). (re operation). Title: laparoscopic posterior mesh rectopexy for rectal prolapse is a safe procedure in older patients: a prospective follow-up study source scandinavian journal of surgery, volume 104, 2015 (227¿232) article number: 7 date of publication: 19 november 2014. If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to literature source of study performed between february 01, 2009 to june 01, 2012 in a tertiary center in denmark 81 eligible patients underwent laparoscopic posterior rectopexy (lpr) with application of the mesh device and secured with four to eight titanium tacks and were followed up to two years with major complications seen in twelve patients (14. 8%) with the first three that could be related to the procedure or the device. Four patients had bleeding (4. 9%), five patients had small bowel obstruction (6. 2%), one patient had deep would infection (1. 2%), one patient had cardiac arrest (1. 2%). These major complications were those that required admission more than three days, re-operation, blood transfusion.

 
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Brand NameSURGIPRO
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 Key8962812
MDR Text Key156802152
Report Number9615742-2019-02994
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeDA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial
Report Date 09/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/04/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN SURGIPRO MESH
Device Catalogue NumberUNKNOWN SURGIPRO MESH
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 Received08/09/2019
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: 09/04/2019 Patient Sequence Number: 1
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