MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UGYTEX; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number UGYKP

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#sfl00436); pelvicol 2cm x 7cm 1.0mm (lot#unknown) (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, 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.

• Brand Name: UGYTEX
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• 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 Key: 9618208
• MDR Text Key: 176034258
• Report Number: 9615742-2020-00192
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• 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 Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UGYKP
• Device Catalogue Number: UGYKP
• Device Lot Number: ZGA00163
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR