ALPHA I NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2003-02-13 for ALPHA I NI manufactured by Mentor Corp - Minnesota Div.

Event Text Entries

[307674] According to the information the device was removed due to deflation, loss of fluid.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2125050-2003-00043
• MDR Report Key: 442635
• Report Source: 07
• Date Received: 2003-02-13
• Date of Report: 2003-01-14
• Date of Event: 2002-11-18
• Date Facility Aware: 2003-01-14
• Date Mfgr Received: 2003-01-14
• Date Added to Maude: 2003-02-14
• 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: 0
• Manufacturer Contact: AL SAALABI
• Manufacturer Street: 1525 WEST RIVER ROAD N
• Manufacturer City: MINNEAPOLIS MN 55411
• Manufacturer Country: US
• Manufacturer Postal: 55411
• Manufacturer Phone: 6122874105
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• 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: ALPHA I
• Generic Name: IPP
• Product Code: FWH
• Date Received: 2003-02-13
• Model Number: NI
• Catalog Number: NI
• Lot Number: NI
• ID Number: NI
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 431617
• Manufacturer: MENTOR CORP - MINNESOTA DIV
• Manufacturer Address: 1525 WEST RIVER RD. NORTH MINNEAPOLIS MN 55411 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2003-02-13