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

Model Number 5196502400

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Reaction (2414); Blood Loss (2597); No Code Available (3191)

Event Date 02/29/2016

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 mixed incontinence, possible exposed mesh/dislodged altis, urgency, uti, sui, vaginal discharge, atrophic and granulation tissue and area of exposed mesh in right vaginal sulcus at the distal urethra, revision of suburethral sling, revision of sling, partial removal of sling for mesh exposure on the right vaginal sulcus, and possible allergic reaction to vicryl sutures.

Manufacturer Narrative

This follow-up mdr is created to document the additional event information received and the corrected event date.

Event Description

As reported to coloplast, though not verified, patient's legal representative stated mixed incontinence, possible exposed mesh/dislodged altis, urgency, uti, sui, vaginal discharge, atrophic and granulation tissue and area of exposed mesh in right vaginal sulcus at the distal urethra, revision of suburethral sling, revision of sling, partial removal of sling for mesh exposure on the right vaginal sulcus, and possible allergic reaction to vicryl sutures.Additional information from patient's legal representative stated severe and debilitating pain, bleeding, urinary infections and urinary retention within days after implantation.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: stephanie perryman ; 1601 west rivier road north; minneapolis, MN 55411 ; 6124345685
• MDR Report Key: 6204667
• MDR Text Key: 63311648
• Report Number: 2125050-2016-00390
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 12/27/2016
• Supplement Dates Manufacturer Received: 12/19/2016
• Supplement Dates FDA Received: 06/30/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR