MAUDE Adverse Event Report: URESIL URESIL ORIGIN; GENERAL PURPOSE LOCKING DRAINAGE CATHETER

Model Number GPL2-0830H

Device Problems Leak/Splash (1354); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 11/08/2019

Event Type  Injury  

Event Description

An 8 fr drain placed in pt's abdominal wall, leaking noted at attachment site.Drain removed and replaced.

• Brand Name: URESIL ORIGIN
• Type of Device: GENERAL PURPOSE LOCKING DRAINAGE CATHETER
• Manufacturer (Section D): URESIL
• MDR Report Key: 9397150
• MDR Text Key: 169018385
• Report Number: 9397150
• Device Sequence Number: 1
• Product Code: GBO
• 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: 11/27/2019

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: Health Professional
• Device Model Number: GPL2-0830H
• Device Catalogue Number: GPL2-0830H
• Device Lot Number: 9F489
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/08/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 91