MAUDE Adverse Event Report: MERIT MEDICAL PERCUTANEOUS NEPHROSTOMY TUBE; MERIT DRAINAGE DEPOT

Model Number 022 OR 2B

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); Blood Loss (2597)

Event Date 11/05/2015

Event Type  Injury  

Event Description

On (b)(6) 2016, i endured an [ir percutaneous - nephrostomy tube placement], while an inpatient at (b)(6).Since this tube placement, i've contracted a kidney infection, and a very bad blood infection in (b)(6) 2017, which required hospitalization for one month.I'm experiencing excruciating pain daily wherein some days i'm so overwhelmed with pain that i can't move until the pain subsides.Lately, i've been having more discharge/drainage than normal.The most adverse effect of this nephrostomy tube and bag, is the constant pain it causes.The tube and bag are frequently filled with blood.During a replacement of this tube, i endured a mass loss of skin and required stitches.The functioning of this tube and bag, is wholly inadequate.See scanned pages.

• Brand Name: PERCUTANEOUS NEPHROSTOMY TUBE
• Type of Device: MERIT DRAINAGE DEPOT
• Manufacturer (Section D): MERIT MEDICAL; 1600 w. merit pkwy; south jordan UT 84095
• MDR Report Key: 7221414
• MDR Text Key: 98462202
• Report Number: MW5074878
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 022 OR 2B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 22 YR
• Patient Weight: 70