Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 UGY1510
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abrasion (1689); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Unspecified Infection (1930); Itching Sensation (1943); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Burning Sensation (2146); Discomfort (2330); Injury (2348); Prolapse (2475); No Code Available (3191); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative
Medtronic complaint report: (b)(4); reporting period march 1 through april 30, 2017.Summarized events on attached spreadsheet for procode ftl: (b)(4) total quantity per brand name: mesh tsl - pelvicol¿ - (b)(4) mesh sofradim - ugytex¿ - (b)(4) mesh ballymoney - ivs tunneller¿ - (b)(4) mesh north haven - surgipro¿ - (b)(4) mesh sofradim - parietex¿ - (b)(4) asr report attached.If information is provided in the future, a supplemental report will be issued.(b)(4).
 
Event Description
(b)(4).
 
Manufacturer Narrative
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.The product was used for therapeutic treatment.It was reported that after a procedure where this device was implanted, the patient experienced urinary tract infections, inability to have sex, burning sensation, itching, discomfort, pain, abrasions, sores, adhesions, constipation, hypertension/high blood pressure, infections, vaginal pain, urinary incontinence, urinary retention, impaired wound healing and nonsurgical intervention.The device had been used with align urethral support system.After the original procedure additional surgeries may have been performed.
 
Manufacturer Narrative
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.The product was used for therapeutic treatment.The patient underwent the placement of a polypropylene mesh.It was reported that after a procedure where this device was implanted, the patient experienced urinary tract infections, inability to have sex, burning sensation, itching, discomfort, pain, abrasions, sores, adhesions, constipation, hypertension/high blood pressure, infections, vaginal pain, urinary incontinence, urinary retention, impaired wound healing and nonsurgical intervention.The device had been used with align urethral support system.After the original procedure additional surgeries may have been performed.
 
Event Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment.It was reported that after a procedure where this device was implanted, the patient experienced urinary tract infections, inability to have sex, burning sensation, itching, discomfort, pain, abrasions, sores, adhesions, constipation, hypertension/high blood pressure, infections, vaginal pain, urinary incontinence, urinary retention, impaired wound healing, bladder pain, urinary tract infection, painful bowel movements, occasional blood in stool, leaking of urine, vulvovaginitis, atrophic vaginitis, monilial candidiasis, constipation, hemorrhoids, rectal prolapse, rectal sphincter pain, posterior fourchette tear, dyspareunia, problems with mesh (sores and abrasions), overactive bladder, stress incontinence, recurrent cystocele and prominence of tot tape without evidence of erosion and nonsurgical intervention.The device had been used with align urethral support system.After the original procedure additional surgeries may have been performed.
 
Manufacturer Narrative
Exemption number: e2013003.Medtronic is submitting this report on behalf of c.R.Bard, inc (importer).C.R.Bard reference number: (b)(4).Uf/importer report number: (b)(4).If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MESH SOFRADIM - UGYTEX¿
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR  01600
MDR Report Key7541976
MDR Text Key109219170
Report Number9615742-2018-01186
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K033376
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor
Type of Report Initial,Followup,Followup,Followup
Report Date 10/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2013
Device Model NumberUGY1510
Device Catalogue NumberUGY1510
Device Lot NumberPID00331
Was Device Available for Evaluation? No
Date Manufacturer Received10/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age79 YR
Patient Weight51
-
-