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); Micturition Urgency (1871); Prolapse (2475); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

This complaint was investigated to the extent information was provided to coloplast.Due to the legal nature of this complaint and the device not being returned for evaluation a thorough investigation could not be executed.Should additional information become available, this file will be re-evaluated and updated according to current procedures.Complaints of this nature are monitored and captured within the product risk documentation.No further action or corrective action is required at this time.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, (b)(6) 2018 - (b)(6) /2021: mild vaginal atrophy, dysuria, frequency, second- degree cystocele, moderate.Feels prolapse is recurring- describes as vaginal bulging, mild vaginal atrophy, third -degree cystocele, moderate.Sui observed during uds, uti, incomplete bladder emptying, urgency of urination, vaginal vault prolapse after hysterectomy, cystocele, midline, acquired vaginal enterocele, cervical stump prolapse, complication of implanted vaginal mesh, recurrence of bladder prolapse.Stage 3 vaginal vault/ cervical stump recurrent prolapse after hysterectomy & sacrocolpopexy, incomplete bladder emptying, need to splint to urinate.Recurrent uti, dysuria and frequency, urinary incontinence without sensory awareness, and constipation.Urinary urgency and vaginal atrophy.No information noting a revision with the altis sling.No other adverse patient effects were reported.

• 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: 13004617
• MDR Text Key: 285733413
• Report Number: 2125050-2021-01772
• 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: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2020
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 5777384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2021
• Date Device Manufactured: 12/12/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female