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

Model Number 5196502400

Device Problem Migration (4003)

Patient Problems Bacterial Infection (1735); Erosion (1750); Emotional Changes (1831); Fistula (1862); Pain (1994); Abnormal Vaginal Discharge (2123); Fungal Infection (2419); Intermenstrual Bleeding (2665); Dyspareunia (4505); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported to coloplast, though not verified, legal representative stated the patient with this device experienced vaginal bleeding, dyspareunia with deep penetration, vaginal discharge, chronic pelvic pain, pelvic adhesions, perineal pain, device exposure and erosion, severe stress urinary incontinence, bacterial vaginosis, monilial vaginitis, tenderness at device erosion, right hip pain, concerned about infected device, retained suture and pain in the obturator fascia bilaterally.Patient had a diagnostic laparoscopy with lysis of pelvic adhesions under general anesthesia.Patient had a bilateral oophorectomy with excision of sub urethral device under general anesthesia.Patient had continued left side pain where part of the device was not removed and a small epithelialized canal where the device was removed.Patient had a small infection near obturator canal on her left obturator where some device material was left.Patient had another explantation of the device.

• 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: 15750182
• MDR Text Key: 303213919
• Report Number: 2125050-2022-01206
• 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
• Report Date: 11/08/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2017
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 4251005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2022
• Initial Date FDA Received: 11/08/2022
• Date Device Manufactured: 11/06/2014
• 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: 39 YR