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

Model Number 5196502400

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Scarring (2061); Dysuria (2684); 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 foreign body reaction, chronic inflammation, excessive scarring, contraction, erosion, dysuria, bladder pain, pelvic pain, dyspareunia.

Manufacturer Narrative

This follow-up is created to document the additional event and device information.The lot number was reviewed for complaint trend, nonconforming reports and capa review.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, additional information received, a mesh excision surgery occurred on (b)(6) 2019, exposure was noted.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: sarah o'gara ; 1601 west river road north; minneapolis, mn, MN 55411 ; 6123024982
• MDR Report Key: 6918831
• MDR Text Key: 88375402
• Report Number: 2125050-2017-00481
• 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: 02/12/2020

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: Physician
• Device Model Number: 5196502400
• Device Catalogue Number: 5196502400
• Device Lot Number: 5076607
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2017
• Initial Date FDA Received: 10/05/2017
• Supplement Dates Manufacturer Received: 09/21/2017
• Supplement Dates FDA Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other