APHI NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-08-30 for APHI NI manufactured by Mentor Corporation - Minnesota Division.

Event Text Entries

[150012] Failed penile prosthesis.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2125050-2000-00009
• MDR Report Key: 293342
• Report Source: 05
• Date Received: 2000-08-30
• Date of Report: 2000-08-30
• Date of Event: 2000-07-11
• Date Facility Aware: 2000-07-31
• Report Date: 2000-08-30
• Date Added to Maude: 2000-08-31
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: DIANE WIERSUM
• Manufacturer Street: 1525 WEST RIVER ROAD NORTH
• Manufacturer City: MINNEAPOLIS MN 55411
• Manufacturer Country: US
• Manufacturer Postal: 55411
• Manufacturer Phone: 6122874111
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: RL
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: APHI
• Generic Name: INFLATABLE PENILE PROSTHESIS
• Product Code: FWN
• Date Received: 2000-08-30
• Model Number: NI
• Catalog Number: NI
• Lot Number: NI
• ID Number: NI
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: UNKNOWN
• Device Eval'ed by Mfgr: R
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 283943
• Manufacturer: MENTOR CORPORATION - MINNESOTA DIVISION
• Manufacturer Address: 1525 W. RIVER ROAD NORTH MINNEAPOLIS MN 55411 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2000-08-30