MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; INFLATABLE PENILE PROSTHESIS

Model Number 5196502400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Fever (1858); Nausea (1970); Pain (1994); Scar Tissue (2060); Sepsis (2067); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Discomfort (2330); Fungal Infection (2419); Dysuria (2684); Dyspareunia (4505); Urinary Incontinence (4572)

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, legal representative stated the patient with this device experienced urinary tract infection, sepsis, intravenous infusion, emergency room visit for urinary tract infection, and a micro report that was positive for e.Coli.

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.

Manufacturer Narrative

Investigation conclusion code corrected.

Event Description

Additional information received on 8/4/2023 states the patient began experiencing dyspareunia, vaginal pain, groin pain, pelvic pain, urinary problems, erosion, recurrence of incontinence, vaginal scarring, and rectal pain, among other symptoms.On or about (b)(6) 2022 the patient sought out care and treatment.The doctor diagnosed patient with mesh complications, has performed many treatments to resolve the complications, and has recommended removal surgery of the altis sling.Patient has not undergone the surgery yet.

Event Description

Additional information received on 10/1/2023 indicates the patient also experienced vaginal discomfort, yeast infection, abnormal vaginal discharge, dysuria, nausea/vomiting, fever, and urinary frequency and urinary retention.The patient was treated with antibiotics and underwent partial removal of the altis sling.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• 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: 15743943
• MDR Text Key: 303160110
• Report Number: 2125050-2022-01200
• 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,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2022
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 6848305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2023
• Date Device Manufactured: 08/14/2019
• 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: 56 YR