NONE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-09-29 for NONE * manufactured by Unk.

Event Text Entries

[116528] Dr used a home made urine catching device, made out of refuge parts. Device came from unsterile packaging. The apparatus was a red 2 inch jar cap with a hole cut in center, and a 5 foot plastic tygon hose inserted in the hole, and was super-glued. The opposite end was put through a rubber pants, with a manual hole cut in the rubber pants. Then it was attached to the pt's vagina, and the pt sat in her wheelchair for 7. 5 hours. The plastic broke through the cap, and inserted itself into the vagina, tearing and cutting the vaginal wall.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1014699
• MDR Report Key: 190691
• Date Received: 1998-09-29
• Date of Report: 1998-09-15
• Date of Event: 1997-08-03
• Date Added to Maude: 1998-10-08
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NONE
• Generic Name: URINE CATCHING DEVICE
• Product Code: EXJ
• Date Received: 1998-09-29
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 185296
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening	1998-09-29