MAUDE Adverse Event Report: COLOPLAST CORP ALTIS; SURGICAL MESH

Model Number 5196502400

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Blood Loss (2597)

Event Date 03/03/2015

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 the plaintiff suffered serious bodily injuries, including but not limited to foreign body reaction, mesh erosion, urinary problems, bleeding, pain, numbness, dyspareunia, difficulty voiding, difficulty emptying bladder, burning sensation, infections and other injuries.

• Brand Name: ALTIS
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST CORP; 1601 west rivier road north; minneapolis MN 55411
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west rivier road north; minneapolis MN 55411
• Manufacturer Contact: sarah o'gara ; 1601 west rivier road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 8634314
• MDR Text Key: 145902525
• Report Number: 2125050-2019-00387
• 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
• Report Date: 05/21/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2019
• Initial Date FDA Received: 05/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other