MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYN, STRESS URINARY INCONT, FEMALE

Model Number 519650

Device Problems Break (1069); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/30/2020

Event Type  malfunction  

Event Description

During insertion of the altis sling, one tip of the applicator broke off during attachment of sling to bone.A second applicator was opened, and used.Patient was taken to pacu where x-ray was taken.Per physician, one tip was located on x-ray near the pelvic bone.It was determined that removing this tip would cause more harm then leaving it in.Patient did not experience any adverse effects and was discharged home as planned.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYN, STRESS URINARY INCONT, FEMALE
• Manufacturer (Section D): COLOPLAST A/S; 1601 west river road north; minneapolis MN 55411
• MDR Report Key: 11193877
• MDR Text Key: 227529630
• Report Number: 11193877
• Device Sequence Number: 1
• Product Code: PAH
• 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: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 519650
• Device Catalogue Number: 519650
• Device Lot Number: 7320737
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2021
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Weight: 109