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

Model Number 5196502400

Device Problem Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Incontinence (1928); Pain (1994); Scarring (2061); Urinary Tract Infection (2120); No Information (3190); No Code Available (3191)

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 incontinence, vaginal pain, pelvic pain, dyspareunia, foreign body reaction, and other injuries.

Manufacturer Narrative

This follow-up mdr is created to document the additional event information, patient dob, explant date, and lot number.The lot number 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

Additional information reported to coloplast, though not verified, indicated the patient reported urinary tract infection, urge incontinence.Stress incontinence had also been reported.The mesh was removed.

Manufacturer Narrative

H6 patient code 3190 selected for voiding dysfunction with urination.H6 patient code 3191 selected for urethral hypermobility.

Event Description

Additional information, as reported to coloplast though not verified, indicated sui, urge incontinence, dyspareunia, incontinence, severe urge incontinence, sui, urethral hypermobility, voiding dysfunction with urination, recurrent urinary tract infections, scarring.(b)(6)2018 - revision of sling, urethrolysis, cystourethroscopy.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8261114
• MDR Text Key: 133537580
• Report Number: 2125050-2019-00040
• 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,Followup
• Report Date: 07/01/2020

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: 5076607
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/18/2019
• Supplement Dates Manufacturer Received: 12/21/2018; 12/21/2018
• Supplement Dates FDA Received: 05/19/2020; 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other