ALPHA I 99185

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 2006-09-22 for ALPHA I 99185 manufactured by Coloplast Manufacturing Us, Llc.

Event Text Entries

[505018] According to the information there was a leak in the reservoir.
Patient Sequence No: 1, Text Type: D, B5

[7834266] An evaluation is pending the decontamination of the component(s). An evaluation will be forwarded upon completion.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2125050-2006-00278
• MDR Report Key: 763927
• Report Source: 05
• Date Received: 2006-09-22
• Date of Event: 2006-08-10
• Date Mfgr Received: 2006-08-24
• Device Manufacturer Date: 1998-01-01
• Date Added to Maude: 2006-09-26
• 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: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: STEVE THEISSEN
• Manufacturer Street: 1525 WEST RIVER ROAD N
• Manufacturer City: MINNEAPOLIS MN 55411
• Manufacturer Country: US
• Manufacturer Postal: 55411
• Manufacturer Phone: *
• 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: INFLATABLE PENILE PROSTHESIS
• Product Code: FWH
• Date Received: 2006-09-22
• Returned To Mfg: 2006-08-24
• Model Number: 99185
• Catalog Number: 99185
• Lot Number: E90293
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Eval'ed by Mfgr: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 751803
• Manufacturer: COLOPLAST MANUFACTURING US, LLC
• 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	2006-09-22