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

Model Number UGYKP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Bradycardia (1751); Micturition Urgency (1871); High Blood Pressure/ Hypertension (1908); Failure of Implant (1924); Incontinence (1928); Pain (1994); Electrolyte Imbalance (2196); Discharge (2225); Anxiety (2328); Discomfort (2330); Injury (2348); Depression (2361); Prolapse (2475); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Pre-op diagnosis: recurrent cystocele, incomplete emptying, urinary frequency, rectal splinting, enterocele.Post-op diagnosis: recurrent cystocele, incomplete emptying, urinary frequency, rectal splinting, enterocele.Name of procedure: anterior posterior repair with repair of enterocele, paravaginal repair, proctopexy, cystoscopy, and placement of anterior and posterior vaginal mesh.Concomitant therapy: pelvisoft alleged complications post implant include recurrent cystocele and rectocele with anterior mesh failure, mesh exposure, incontinence, occasional urge, decreased libido, recurrent prolapse including anterior and apical prolapse.Mesh revision surgery (b)(6) 2007.

Manufacturer Narrative

(b)(4) - unspecified urinary problems, pressure, post void residuals, decreased libido, vaginal rugae, soreness, nonsurgical and additional surgical interventions.If information is provided in the future, a supplemental report will be issued.

Event Description

Per additional information received, the patient has experienced mesh exposure, pain, erosion, unspecified urinary problems, leakage, pelvic pressure, urinary incontinence, opening in epithelium, enterocele/cystourethrocele/rectocele (prolapse), pelvic support defect, discharge, failure of implant, post void residuals, decreased libido, discomfort, urinary urgency, vaginal rugae, elevated blood urea nitrogen/creatinine, low blood urea nitrogen/creatinine, low calcium/sodium (electrolyte imbalance), bradycardia, elevated white blood cells, low hematocrit/hemoglobin/red blood cells, elevated blood pressure, anxiety, soreness, depression, nonsurgical and additional surgical interventions.

• 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
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6773419
• MDR Text Key: 82030898
• Report Number: 9615742-2017-05200
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2011
• Device Model Number: UGYKP
• Device Catalogue Number: UGYKP
• Device Lot Number: ZGA00073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2017
• Date Device Manufactured: 01/01/2006
• 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): Other; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 80