MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; SURGICAL MESH

Model Number 5196502400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Pain (1994); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Device not returned.

Event Description

As reported to coloplast, though not verified, between (b)(6) 2017-(b)(6) 2021: pvr= 203, urgency, lower abdominal pain, feeling of needle poking, urge incontinence, uti in (b)(6), flexible cystoscopy: normal high post void residual, back discomfort that claimant feels is linked to altis sling, hematuria, flexible cystoscopy: normal bladder.Mesh visible anterior vaginal wall, palpable mesh on the anterior vaginal wall, mixed incontinence primarily urge incontinence, anterior vaginal mesh exposure, urinary and fecal incontinence.Vaginal discharge, vaginal bleeding, vaginoscopy: small defect anterior vaginal wall.Persistent vaginal discharge.Additional information received on vague mild abdominal pain, suprapubic and right groin pain, uti, cultures negative on (b)(6) 2016, mixed incontinence, uti, positive cultures on (b)(6) 2020, vaginal discharge, offensive smell, urine and fecal incontinence, bacterial vaginitis, vaginal discharge/infection, vaginal bleeding.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12833274
• MDR Text Key: 282276246
• Report Number: 2125050-2021-01662
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932467407
• UDI-Public: 05708932467407
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female