MAUDE Adverse Event Report: COLOPLAST A/S ALTIS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE

Catalog Number 519650

Device Problems Break (1069); Loose or Intermittent Connection (1371)

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

Event Date 12/12/2019

Event Type  malfunction  

Event Description

Dart broke loose and did not stay on sling for implantation.

• Brand Name: ALTIS
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE
• Manufacturer (Section D): COLOPLAST A/S; 1601 west river road; minneapolis MN 55411
• MDR Report Key: 10448041
• MDR Text Key: 204194822
• Report Number: 10448041
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 519650
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1