MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC. COAPTITE; AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Catalog Number M006890300

Device Problem Difficult to Advance (2920)

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

Event Date 05/23/2018

Event Type  malfunction  

Event Description

The coaptite implant was hard to push through syringe and needle.Staff opened a second syringe with same lot number and then a third syringe with a different lot number.They all had the same issue.Staff opened the second needle and had the same issue.

• Brand Name: COAPTITE
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): MERZ NORTH AMERICA, INC.; 6501 six forks road; raleigh NC 27615
• MDR Report Key: 7604942
• MDR Text Key: 111199939
• Report Number: 7604942
• Device Sequence Number: 1
• Product Code: LNM
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/06/2018

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: 11/02/2021
• Device Catalogue Number: M006890300
• Device Lot Number: 100103908
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR