MAUDE Adverse Event Report: COLOPLAST A/S ALTIS KIT; SURGICAL MESH

Model Number 5196502400

Device Problem Extrusion (2934)

Patient Problems Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scarring (2061); Urinary Tract Infection (2120); Urinary Frequency (2275); Discomfort (2330); Blood Loss (2597); Dysuria (2684); No Information (3190); No Code Available (3191)

Event Date 05/22/2015

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast though not verified, patient's legal representative stated female stress incontinence and failed previous suburethral sling, pain, extrusion, recurrence, infection, bleeding, dyspareunia, urinary problems, vaginal scarring, other.

Event Description

As reported to coloplast though not verified, additional information stated frequency and nocturia, recurrent stress urinary incontinence.(b)(6) 2016 - (b)(6) 2018 - multiple visits with positive urine cultures and symptoms of uti with right flank pain, dysuria, pelvic pressure malodourous urine, frequency, suprapubic discomfort and back pain.(b)(6) 2018 - cystoscopy for continued uti and urge incontinence symptoms,chronic cystitis with current uti.Undergoes uds, renal us and a cystoscopy with no anesthesia.Sui noted on uds, no treatment indicated.Normal cystoscopy with no sui noted, diagnosed with atrophic vaginitis and urge incontinence.Treated for urge incontinence and atrophic vaginitis.

Manufacturer Narrative

(b)(4).Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7586240
• MDR Text Key: 110587609
• Report Number: 2125050-2018-00447
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 5196502400
• Device Catalogue Number: 5196502400
• Device Lot Number: 4230883
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 06/11/2018
• Supplement Dates Manufacturer Received: 05/16/2018
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR