MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC COLOPLAST INTERNAL CATHETER; CATHETER, RETENTION TYPE, BALLOON

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hematuria (2558); Blood Loss (2597)

Event Date 12/30/2016

Event Type  Injury  

Event Description

I was prescribed fluphenazine then aripiprazole which caused my weight to increase and made me despondent.Wt: (b)(6) 2016, (b)(6) lbs, (b)(6) 2020, (b)(6) lbs.I was also filled with an internal catheter which eventually caused excessive bleeding.I experienced blood in my urine for the first time, while i was unconscious.Many of my upper teeth were extracted.

• Brand Name: COLOPLAST INTERNAL CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COLOPLAST MANUFACTURING US, LLC
• MDR Report Key: 10718083
• MDR Text Key: 212742188
• Report Number: MW5097385
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): Y
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 72 YR
• Patient Weight: 91