MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC ALTIS SLING; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Catalog Number 519650

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2020

Event Type  malfunction  

Event Description

Md attempted in insert altis single incision sling, but suture popped off rendering product unusable.Fda safety report id # (b)(4).

• Brand Name: ALTIS SLING
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• Manufacturer (Section D): COLOPLAST MANUFACTURING US, LLC
• MDR Report Key: 10875491
• MDR Text Key: 217685783
• Report Number: MW5098001
• Device Sequence Number: 1
• Product Code: PAH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/11/2023
• Device Catalogue Number: 519650
• Device Lot Number: 7273367
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 83