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

Model Number 519650

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/18/2021

Event Type  malfunction  

Event Description

Mesh ripped when doctor pulled on it.Some of the mesh is still in the patient.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): COLOPLAST A/S; 1601 west river road north; minneapolis MN 55411
• MDR Report Key: 11607456
• MDR Text Key: 243560339
• Report Number: 11607456
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 519650
• Device Lot Number: 7332038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Weight: 63