STAMEN PUMP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-16 for STAMEN PUMP manufactured by Stamen's.

Event Text Entries

[20941694] My husband used a pump device for erectile dysfunction three days before he suffered a very very bad stroke and then, bled on top of the stroke. This was the one and only time he had used the device! He had been walking 2 1/2 miles most every day and had lost weight on purpose. He was an active person who would go fishing anytime invited. He took care of me for 9 months while i was healing from a broken leg/ankle! He fought valiantly to stay alive for 13 days. He gave up the fight at 2pm in the afternoon. I didn't think to share this info with his drs. At the hospital - i didn't put 2 and 2 together until recently---i wouldn't be surprised if other men die from using this device. I remember how stressful it was for him to use it and how he exerted himself. I have told the manufacturer - via phone - of my suspicions. I hope this device will be pulled from the market place before any more faithful husbands die from trying to recapture their youth! Diagnosis or reason for use: erectile dysfunction.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5014015
• MDR Report Key: 1562934
• Date Received: 2009-12-16
• Date of Report: 2009-12-15
• Date of Event: 2009-08-19
• Date Added to Maude: 2009-12-28
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STAMEN PUMP
• Generic Name: NONE
• Product Code: LST
• Date Received: 2009-12-16
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STAMEN'S

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2009-12-16