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

Model Number 5196502400

Device Problems Device Appears to Trigger Rejection (1524); Material Too Rigid or Stiff (1544); Patient-Device Incompatibility (2682); Material Twisted/Bent (2981)

Patient Problems Erosion (1750); Inflammation (1932); Nerve Damage (1979); Pain (1994); Tissue Damage (2104); No Information (3190)

Event Date 09/30/2019

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.(b)(4).

Event Description

As reported to coloplast though not verified, patient's legal representative stated pelvic and vaginal pain and suffering, complex extrusion and erosion of the mesh in her [plaintiff] body, chronic inflammation with swollen and inflamed tissue in her vagina, mesh adhesion to her vagina and surrounding tissue, tissue damage and death of her vaginal wall tissue and nerves, failure of the mesh to treat her underlying conditions, new onset urinary and pelvic complications, mesh deformation including coiling, contracting and curing of the mesh inside her vagina, mesh hardening and stiffening, intervention for her pain including the need for painful surgical intervention to remove segments of the eroded mesh, need for continuing and future medical care and treatment, operation to locate and remove fragments of the mesh, operation to attempt to repair pelvic organs, tissue and nerve damage and use of pain control and other medications, injections into various areas of the pelvis, spine and vagina and operations to remove portions of the female genitalia.

Event Description

This follow-up mdr is created to document the additional event information received for record # (b)(6).Which states patient experienced vaginal discomfort, urinary urgency, wound dehiscence on (b)(6) 2019 residual suture noted/removed, (b)(6) 2019 dysuria, uti., (b)(6) 2019: pain, exposure of entire suburethral portion of mesh, and on (b)(6) 2019: partial excision of exposed mesh.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information no further corrective action is required at this time.This complaint was investigated to the extent information was provided to coloplast.Due to the legal nature of this complaint, the device not being returned for evaluation and the implanted device lot number not being provided, 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.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9930683
• MDR Text Key: 188370627
• Report Number: 2125050-2020-00315
• 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: other
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention