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

Model Number 5196502400

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Incontinence (1928)

Event Type  Injury  

Manufacturer Narrative

The contract manufacturer was notified of the reported complaint.However, as no lot number was provided, a review of the device history record, complaint history database, non-conformances and capas could not be completed.No components were received for evaluation as the device remains implanted.As examination of the components may not conclusively confirm or disprove the report of leakage quality accepts the physician's observations.

Event Description

According to the available information, the altis was placed in (b)(6) 2019, and reported to have failed that same month.The patient was reported to have recovered without sequelae and the sling had been placed too loose (not tensioned enough).It was later reported the patient had a redo surgery because the patient wasn't dry.According to the coloplast territory manager, after going in and looking at the position of the sling it did not appear to be an issue with the sling, or placement of the sling.The physician felt the sling was a bit anterior and the patient had a long urethra which could have contributed to the issue.A non-coloplast device was placed on top of the altis.The altis was left untouched due to tissue ingrowth, and it was also reported that one sling was not wide enough to cover the areas needed to give the patient support.

Manufacturer Narrative

This follow-up mdr is created to document the corrected information: d5 - operator of device was healthcare professional d7 - explant date was entered in error.The date of surgery was (b)(6)2019, but the device was not explanted.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9568500
• MDR Text Key: 174476698
• Report Number: 2125050-2020-00024
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

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: 12/10/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 12/10/2019
• Supplement Dates FDA Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other