MAUDE Adverse Event Report: ALTIS SINGLE INCISION SLING SYSTEM; SURGICAL MESH

Model Number 5196502400

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Erosion (1750); Foreign Body Reaction (1868); Burning Sensation (2146); Dyspareunia (4505); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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, a legal representative stated foreign body reaction, pain, dyspareunia, difficulty voiding, difficulty emptying bladder, burning sensation, infections an other injuries.

Event Description

Additional information received further reported that in (b)(6) 2019, the patient was experiencing or had experienced mesh exposure, dyspareunia, and urinary incontinence.Partial sling removal took place under general anesthesia.Intraoperative findings revealed a 0.5cm mesh erosion suburethral, with hypermobile bladder neck and friable granulation tissue.

Manufacturer Narrative

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

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• MDR Report Key: 11797221
• MDR Text Key: 249691732
• Report Number: 2125050-2021-00483
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2020
• Device Model Number: 5196502400
• Device Lot Number: 5673422
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention