AMS IPP 72401457 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-21 for AMS IPP 72401457 * manufactured by Unk.

Event Text Entries

[18147011] Failed penile implant.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 535705
• MDR Report Key: 535705
• Date Received: 2004-07-21
• Date of Report: 2004-07-16
• Date of Event: 2004-07-13
• Date Facility Aware: 2004-07-16
• Report Date: 2004-07-16
• Date Reported to FDA: 2004-07-16
• Date Added to Maude: 2004-07-26
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AMS IPP
• Generic Name: PENILE PROSTHESIS
• Product Code: FWH
• Date Received: 2004-07-21
• Model Number: 72401457
• Catalog Number: *
• Lot Number: 331739001
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 524949
• Manufacturer: UNK
• Manufacturer Address: UNK UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2004-07-21