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

Model Number 5196501022

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Urinary Retention (2119)

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

Patient experienced urinary retention after altis procedure.Description of the event : after miction large residue : post void residual volume = 850ml.Treatment : prolongation of hospitalization (1 additional day) - intermittent urinary drainage.Status of the event : on going.Device remains implanted.

Manufacturer Narrative

This follow-up mdr is created to document additional information received indicating this event has been resolved on (b)(6) 2017.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

Patient experienced urinary retention after altis procedure.Onset event : (b)(6) 2017.Description of the event : after miction large residue : post void residual volume = 850 ml.Treatment : prolongation of hospitalization (1 additional day) - intermittent urinary drainage.Status of the event : resolved on (b)(6) 2017.

• 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: christine buckvold
• MDR Report Key: 6457945
• MDR Text Key: 71679830
• Report Number: 2125050-2017-00058
• 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: foreign,study
• Type of Report: Initial,Followup
• Report Date: 04/05/2017

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: 5196501022
• Device Catalogue Number: 5196501022
• Device Lot Number: 5094536
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2017
• Initial Date FDA Received: 04/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/05/2017
• 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
• Patient Age: 47 YR