MAUDE Adverse Event Report: COLOPLAST A/S ALTIS KIT; SURICAL MESH

Model Number 5196502400

Device Problem Insufficient Information (3190)

Patient Problems Incontinence (1928); Pain (1994); Injury (2348); Obstruction/Occlusion (2422); Prolapse (2475); No Information (3190)

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, patient's legal representative stated plaintiff suffered abdominal pain, painful intercourse, recurrent urinary symptoms, voiding dysfunction, and incomplete emptying.Plaintiff underwent a surgical procedure during which her physicians excised and removed a portion of the mesh for management of her obstructive voiding symptoms.Plaintiff has suffered, and continues to suffer, multiple, severe and painful personal injuries, including, but not limited to, vaginal prolapse, urinary incontinence, physical deformity, and the loss of the ability to perform sexually.

Manufacturer Narrative

This follow-up mdr is created to document the lot review performed.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

• Brand Name: ALTIS KIT
• Type of Device: SURICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9432528
• MDR Text Key: 169846321
• Report Number: 2125050-2019-01077
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Lot Number: 3513873
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other