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

Model Number 5196502400

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Micturition Urgency (1871); Pain (1994); Dyspareunia (4505); Genital Bleeding (4507); Urinary Incontinence (4572)

Event Date 06/19/2020

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.

Event Description

As reported to coloplast, though not verified, the patient with this device experienced complications associated with transvaginal mesh products such as inter alia, dyspareunia, severe pelvic pain, urinary urgency problems, incontinence, and difficulty with daily activities.

Event Description

Additional information received on 02/08/2023 indicates that beginning 2/12/2018 the patient experienced trace blood and during intercourse, the husband felt something which resulted in a cut.Mesh visualized and palpated on anterior vaginal wall, extensive exposure of mid-urethral mesh.On 6/19/2020 vaginal exploration with complete removal of the altis sling.

Manufacturer Narrative

Correction: medical device term and investigation conclusion term.

• 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 14655876
• MDR Text Key: 293830385
• Report Number: 2125050-2022-00599
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/20/2019
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 4985237
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2023
• Date Device Manufactured: 04/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female