MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC ALTIS; MESH, SURGICAL, SYNTHETIC

Model Number 519650

Device Problems Positioning Failure (1158); Disassembly (1168); Split (2537)

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

Event Date 10/28/2016

Event Type  malfunction  

Event Description

While the surgeon was performing routine procedure using the product, he was able to complete the first step of the technique.However, when he attempted to complete the second pass, the anchor did not engage.The adjusting mechanism came apart.The first side of the device was anchored in and did not come loose.The device split in two pieces.

• Brand Name: ALTIS
• Type of Device: MESH, SURGICAL, SYNTHETIC
• Manufacturer (Section D): COLOPLAST MANUFACTURING US, LLC; 1601 west river road; minneapolis MN 55411
• MDR Report Key: 6145166
• MDR Text Key: 61442515
• Report Number: 6145166
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/15/2016
• Device Model Number: 519650
• Device Catalogue Number: 519650
• Device Lot Number: 5076609
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NO OTHER THERAPIES
• Patient Age: 79 YR
• Patient Weight: 66