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

Model Number 5196502400

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Erosion (1750); Emotional Changes (1831); Pain (1994); Deformity/ Disfigurement (2360); Sexual Dysfunction (4510); Urinary Incontinence (4572)

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, legal representative stated the patient with this device experienced stress urinary incontinence, mechanical dysfunction of genitourinary device and device exposure in right sulcus.Patient had explantation of the device and cystourethroscopy with urethral dilation via general anesthesia.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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

Additional information received on 5/1/2023 as follows: the patient was caused to suffer, and did suffer, the serious and dangerous side effects of erosion of the vaginal wall and other tissues, permanent and substantial physical deformity and loss of the ability to perform sexually and has undergone corrective surgeries that will likely require a further collective surgery, and suffered further grievous personal injuries, including, but not limited to, physical pain and mental anguish, permanently diminished enjoyment of life, and any and all additional life implications and complications such as the patient's need for life-long medical treatment and care.

• 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: 16406657
• MDR Text Key: 309863284
• Report Number: 2125050-2023-00202
• 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: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 7261727
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2023
• Date Device Manufactured: 07/01/2020
• 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: 73 YR