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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS URETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number URETEXTO2
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Erosion (1750); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Injury (2348); Prolapse (2475); Hematuria (2558); Blood Loss (2597); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products-(lot# zga00163). (b)(4). 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 of pelvic prolapse and stress incontinence. It was reported that after implant, the patient experienced recurrent stress urinary incontinence, cystocele (prolapse), mesh extrusion, pain, erosion, infection, unspecified urinary problems, recurrence, dyspareunia, acute cystitis, hematuria, atrophic vaginitis, exposure of vaginal mesh into vagina, incontinence of feces, sexual dysfunction, recurrent uti's, urinary frequency, and vaginal bleeding. Post-operative patient treatment included additional surgical interventions.
 
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Brand NameURETEX
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 Key9618216
MDR Text Key176034766
Report Number9615742-2020-00191
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041176
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 01/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/01/2010
Device Model NumberURETEXTO2
Device Catalogue NumberURETEXTO2
Device Lot NumberSFL00436
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2020
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: 01/22/2020 Patient Sequence Number: 1
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