MENTOR FREEDOM-CATH-MEDIUM 26-08200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1997-10-27 for MENTOR FREEDOM-CATH-MEDIUM 26-08200 manufactured by Mentor Urology, Inc..

Event Text Entries

[113164] The pt has developed a skin irritation on the shaft and head of the penis which manifest as blisters, redness and tenderness. The pt has been seen by a physician and is being treated with antibiotics. A "wound" is noted on the glans end of the penis. Current treatment includes leaving the skin exposed to allow symptoms to subside. A latex reaction maybe a contributing factor.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2183558-1997-00014
• MDR Report Key: 128289
• Report Source: 04
• Date Received: 1997-10-27
• Date of Report: 1997-09-26
• Date Mfgr Received: 1997-09-26
• Date Added to Maude: 1997-10-28
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Remedial Action: RL
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MENTOR FREEDOM-CATH-MEDIUM
• Generic Name: MALE EXTERNAL CATHETER
• Product Code: EXJ
• Date Received: 1997-10-27
• Model Number: NA
• Catalog Number: 26-08200
• Lot Number: NA
• ID Number: NA
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: NA
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 125519
• Manufacturer: MENTOR UROLOGY, INC.
• Manufacturer Address: 1815 WEST RIVER ROAD N. MINNEAPOLIS MN 55411 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-10-27