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 Abdominal Pain (1685); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Anxiety (2328); Abdominal Cramps (2543); Hematuria (2558); Dysuria (2684); Neuralgia (4413); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); 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 dyspareunia, pelvic pain, vaginal pain, recurring urinary incontinence, recurring urinary tract infections, depression, anxiety, severe permanent pain, disability, impairment of mobility, impairment of bowel and bladder function, impairment of sexual function, and future explantation of the device.The patient was diagnosed with pudendal neuralgia and underwent explantation as well as pudendal nerve blocks, and is receiving ongoing medical treatment for her injuries.Patient suffered from pre-existing injuries or conditions which were aggravated, exacerbated, and/or accelerated by implantation of the device.

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

The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

Event Description

Additional information received on 11/12/2022 as follows: beginning (b)(6) 2017 through (b)(6) 2021 the patient was experiencing one or more of the following: hematuria, urinary frequency and chronic intermittent dysuria with hematuria.Chronic abdominal pain.Pelvic floor muscle spasms.

• 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: 15505030
• MDR Text Key: 300802137
• Report Number: 2125050-2022-01000
• 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: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 5167779
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2022
• 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 Sex: Female