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

Catalog Number 519650

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2019

Event Type  malfunction  

Event Description

Doctor anchored second side but when tried to tension the sling, the suture broke and tensioning couldn't be completed.Doctor removed everything but the dynamic anchor of subject altis and implanted a second altis uneventfully.

• Brand Name: ALTIS
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE
• Manufacturer (Section D): COLOPLAST MANUFACTURING US, LLC; 1601 w river rd n; minneapolis MN 55411
• MDR Report Key: 9207943
• MDR Text Key: 162864236
• Report Number: 9207943
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 519650
• Device Lot Number: 6306258
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2019
• Type of Device Usage: N
• Patient Sequence Number: 1