KIT, AMS ACCESSORY *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-26 for KIT, AMS ACCESSORY * manufactured by Ams.

Event Text Entries

[2716454] An inflatable penile prosthesis was removed. The surgical report indicates the reason for removal was erosion.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2576446
• MDR Report Key: 2576446
• Date Received: 2012-04-26
• Date of Report: 2012-04-26
• Date of Event: 2012-04-20
• Report Date: 2012-04-26
• Date Reported to FDA: 2012-04-26
• Date Added to Maude: 2012-05-16
• 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: 0
• Reporter Occupation: RISK MANAGER
• 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 Sequence Number: 1

• Brand Name: KIT, AMS ACCESSORY
• Generic Name: IPP (ACCESSORY KIT)
• Product Code: JCW
• Date Received: 2012-04-26
• Model Number: *
• Catalog Number: *
• Lot Number: 832698817
• ID Number: *
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AMS
• Manufacturer Address: 10700 BREN ROAD WEST MINNETONKA MN 55343 US 55343

Device Sequence Number: 2

• Brand Name: PUMP, MS
• Generic Name: IPP (PUMP)
• Product Code: JCW
• Date Received: 2012-04-26
• Model Number: *
• Catalog Number: *
• Lot Number: 616728003
• ID Number: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: AMS
• Manufacturer Address: 10700 BREN ROAD WEST MINNETONKA MN 55343 US 55343

Device Sequence Number: 3

• Brand Name: RESERVOIR, AMS 700
• Generic Name: IPP (RESERVOIR)
• Product Code: JCW
• Date Received: 2012-04-26
• Model Number: *
• Catalog Number: *
• Lot Number: 624230009
• ID Number: *
• Device Availability: Y
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: AMS
• Manufacturer Address: 10700 BREN ROAD WEST MINNETONKA MN 55343 US 55343

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-04-26