MAUDE Adverse Event Report: SOFRADIM PRODUCTION PARIETEX UGYTEX PP ANTERIOR KIT X1; MESH, SURGICAL, POLYMERIC

Model Number UGYKA

Device Problems Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Incontinence (1928); Scarring (2061); Urinary Tract Infection (2120); Injury (2348); Prolapse (2475)

Event Date 10/25/2006

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, the patient underwent stress urinary incontinence and pelvic organ prolapse repair with two covidien mesh devices.As a result of the sling slipping, the patient experienced recurrent incontinence and subsequently underwent a second repair with two additional covidien meshes.She continued to have pelvic fullness and bloating, urgency, right upper quadrant pain, frequency, right lower back pain, painful burning sensation in right groin with right leg pain in a.M., recurrent and chronic urinary tract infections, removal of 2 colon polyps, urge incontinence, pain in right butt cheek, fecal incontinence, chronic cystitis, urinary retention, on exam was found to have palpable mesh anteriorly with overcorrection of the entire anterior segment, vaginal pain, dyspareunia, vaginal scarring, eroded mesh, vaginal prolapse and shortened vaginal canal.The patient underwent bilateral paravaginal dissection, bilateral pararectal dissection, removal of sling, urethral lysis, removal of mesh, anterior and posterior colporrhaphy on (b)(6) 2014.She then continued to have minimal sensation to bladder filling, genuine stress urinary incontinence, rectocele, prolapse of vaginal vault, a high compliance bladder, vaginal enterocele and cystocele.The patient underwent sacrospinous colpopexy, sling urethropexy, cystocele repair, anterior colporrhaphy, rectocele repair, posterior colporrhaphy, colpoperineorrhaphy, and suprapubic tube placement on (b)(6) 2014.

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 stress urinary incontinence, urinary tract infections, vaginal pain, dyspareunia, vaginal scarring, exposed mesh, vaginal prolapse, and shortened vaginal canal.

Manufacturer Narrative

Exemption number: e2013003.Medtronic is submitting this report on behalf of c.R.Bard, inc (importer) c.R.Bard reference number: 813855 uf/importer report number: 1018233 medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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.

• Brand Name: PARIETEX UGYTEX PP ANTERIOR KIT X1
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• MDR Report Key: 5653210
• MDR Text Key: 45142369
• Report Number: 9615742-2016-00026
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K033376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2011
• Device Model Number: UGYKA
• Device Catalogue Number: UGYKA
• Device Lot Number: ZGB00242
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: URETEXSUP ((B)(6) 2006); URETEXSUP ((B)(6) 2006)
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 109