MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; SURGICAL MESH

Model Number 5196502400

Device Problem Device-Device Incompatibility (2919)

Patient Problem Pain (1994)

Event Date 06/30/2020

Event Type  Injury  

Manufacturer Narrative

The lot # 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

Physician felt it was a leg positioning injury and not the sling and wanted to allow time to heal.Patient opted to have sling removed a week later.Patient had no pain, is now incontinent, and doesn't want another sling at this time.

Event Description

This follow-up mdr is created to document the additional event information received for record #609640.According to the available information received from the territory manager: ¿came to my attention today this patient had post op groin pain.Physician felt it was a leg positioning injury and not the sling and wanted to allow time to heal.Patient opted to have sling removed a week later.Patient had no pain, is now incontinent, and doesn¿t want another sling at this time¿.No components were received for evaluation.As examination of the components may not conclusively confirm or disprove the report of pain quality accepts the physician¿s observations as to the reason for surgical intervention.As no lot # was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed.

Manufacturer Narrative

Based on the available information, the reported complaint is identified in the risk management documentation and reviewed routinely with management to monitor complaint trends as part of post market surveillance.No corrective action is required at this time.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 10584544
• MDR Text Key: 208511352
• Report Number: 2125050-2020-00884
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/24/2020
• Supplement Dates Manufacturer Received: 08/25/2020
• Supplement Dates FDA Received: 10/29/2020
• Patient Sequence Number: 1