MAUDE Adverse Event Report:; SURGICAL MESH

Device Problem Material Erosion (1214)

Patient Problems Fistula (1862); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Pocket Erosion (2013); Scar Tissue (2060); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Discomfort (2330); Prolapse (2475); Blood Loss (2597); Dysuria (2684); No Information (3190); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This mdr is created as a follow-up to record (b)(4), initially reported on product code otn asr exemption # e2014015 for february-march 2015.This mdr is to reflect the additional information (event information, medical history) to be added to the intial asr report.(b)(4).Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

This mdr is created as a follow-up to record (b)(4), initially reported on product code otn asr exemption # e2014015 for february-march 2015.This mdr is to reflect the additional information to be added to the initial asr report.The original information, reported to coloplast though not verified, indicated the patient experienced incomplete emptying, tiny mesh erosion, pelvic pain, mesh erosion, uterine prolapse, bleeding, scarring, infection and urinary problems.A hysterectomy, d & c and a removal of mesh were performed on (b)(6) 2014.A total vagina hysterectomy, anterior colporrhaphy, uterosacral suspension and excision of mesh erosion were performed on (b)(6) 2014.A follow up exam performed on (b)(6) 2014 showed normal suture lines, good approximation and no active bleeding or odor.Additional information, as reported to coloplast though not verified, indicated small mesh erosion, feeling of incomplete emptying, rectocele, urge, frequency, dysuria, discomfort with standing, uterine prolapse, slowness to urine stream, incomplete emptying, vaginal bleeding, pelvic pain, uterine prolapse and cystocele, abnormal bleeding, mesh erosion tender on palpation.On (b)(6) 2014 - hysteroscopy, d&c and removal of mesh erosion under general anesthesia.On (b)(6) 2014 - total vaginal hysterectomy, anterior colporrhaphy, uterosacral suspension, excision of mesh erosion under general anesthesia.On (b)(6) 2015 - leaking urine, stress incontinence and pelvic pain, urine leakage worsening, pelvic pressure, llq pain, urinary incontinence and leakage, nocturia, possible rectovaginal fistula, increased frequency, atrophic vaginitis, sensation of bladder fullness.On (b)(6) 2018 - mixed urinary incontinence, chronic vaginal pain, intermittent vaginal discharge, suburethral tenderness, dyspareunia, grade 3 cystocele, tender proximal mesh band with palpation.It was also reported the patient was implanted with a novasilk mesh on the same day.This information for novasilk is also reported under 2125050-2020-00418.

• Type of Device: SURGICAL MESH
• Manufacturer Contact: stephanie perryman ; 1601 west river road north; minneapolis, mn
• MDR Report Key: 10137191
• MDR Text Key: 202582709
• Report Number: 2125050-2020-00417
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1