• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - UGYTEX¿ MESH, SURGICAL, POLYMERIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SOFRADIM PRODUCTION SAS MESH SOFRADIM - UGYTEX¿ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UGYKA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Injury (2348); Prolapse (2475)
Event Type  Injury  
Manufacturer Narrative
This event was previously reported to the fda on an alternative summary report (asr approval #: e2013038) which is no longer in effect. Because of additionally received complaint information, this and all further updates will be submitted through the 3500a form. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient's attorney alleged a deficiency against the device. Product was used for therapeutic treatment of cystocele/enterocele in an anterior repair with mesh graft and cystoscopy. Post implant complications include a procedure on (b)(6) 2014 for treatment of bilateral ovarian cysts and pelvic floor prolapse, implant of matristem, diagnostic laparoscopy, lysis of adhesions, bilateral salpingectomy and oophorectomy, tvt urethropexy, reduction of enterocele, and cystoscopy under endotracheal anesthesia. There was also a (b)(6) 2015 procedure for pelvic floor prolapse, including a second additional implant, robotic sacrocolpopexy with y-mesh, and cystoscopy.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMESH SOFRADIM - UGYTEX¿
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 Key8824972
MDR Text Key152171554
Report Number9615742-2019-02657
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2011
Device Model NumberUGYKA
Device Catalogue NumberUGYKA
Device Lot NumberZGF00753
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2019
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: 07/25/2019 Patient Sequence Number: 1
-
-