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

Model Number UGYKP

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Erosion (1750); Breast Cancer (1759); Cellulitis (1768); Emotional Changes (1831); High Blood Pressure/ Hypertension (1908); Failure of Implant (1924); Incontinence (1928); Pain (1994); Weakness (2145); Cramp(s) (2193); Discharge (2225); Anxiety (2328); Distress (2329); Injury (2348); Disability (2371); Prolapse (2475); Blood Loss (2597); Abdominal Distention (2601); No Code Available (3191); Constipation (3274)

Event Type  Injury  

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 of prolapsed uterus and urinary incontinence.It was reported that after implant, the patient experienced device failure, pain, bleeding, protrusion, fear of sexual intercourse, upset emotional distress, embarrassment, uterus again bulging, inability to lift or strain, recurrent urinary incontinence, recurrent prolapse, erosion, stage i breast cancer, hypertension, and vaginal pain.Post-operative patient treatment included hysterectomy, device removal, and estrogen cream.

Manufacturer Narrative

H6:patient code- (b)(6).(inability to lift or strain).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.The product was used for therapeutic treatment of prolapsed uterus and urinary incontinence.It was reported that after implant, the patient experienced device failure, pain, bleeding, protrusion, fear of sexual intercourse, upset emotional distress, embarrassment, uterus again bulging, inability to lift or strain, recurrent urinary incontinence, recurrent prolapse, erosion, stage i breast cancer, hypertension, vaginal pain, pelvic floor weakness, discharge/spotting/pain, intermittent lower cramping, and constipation.Post-operative patient treatment included hysterectomy, device removal, and estrogen cream.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.The product was used for therapeutic treatment of prolapsed uterus and urinary incontinence.It was reported that after implant, the patient experienced device failure, pain, bleeding, protrusion, fear of sexual intercourse, upset emotional distress, embarrassment, uterus again bulging, inability to lift or strain, recurrent urinary incontinence, recurrent prolapse, erosion, stage i breast cancer, hypertension, vaginal pain, pelvic floor weakness, discharge/spotting/pain, intermittent lower cramping, and constipation.Post-operative patient treatment included hysterectomy, device removal, and estrogen cream.

• 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
• MDR Report Key: 8697759
• MDR Text Key: 147953297
• Report Number: 9615742-2019-02187
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K051503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2011
• Device Model Number: UGYKP
• Device Catalogue Number: UGYKP
• Device Lot Number: ZGE00582
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UGYKA(LOT#: ZGC00002), URETEXTO2(LOT#: SGH00297)
• Patient Outcome(s): Required Intervention
• Patient Weight: 59