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

Model Number 5196502400

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Dyspareunia (4505); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported to coloplast, though not verified, the patient with this product experienced mesh erosion through the vaginal epithelium and required excision of the mesh with lma.No other adverse patient effects were reported.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.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.Additional review determined h6 codes a040503 "material erosion" and e2403 "no clinical signs, symptoms or conditions" were applied in error.

Event Description

Additional information received further reported that the patient experienced severe and debilitating pain, dyspareunia, urinary incontinence, urinary tract infection, and mesh erosion.

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

Add'l info rec'd 6/8/2021, as reported to coloplast, though not verified, plaintiff experienced severe and debilitating pain, dyspareunia, urinary incontinence, urinary tract infections, mesh erosion.Mesh removed on (b)(6) 2020.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11811465
• MDR Text Key: 250177827
• Report Number: 2125050-2021-00499
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR