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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS INC AMS INFLATABLE PENILE PROSTHESIS
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AMERICAN MEDICAL SYSTEMS INC AMS INFLATABLE PENILE PROSTHESIS Back to Search Results
Device Problem Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2015
Event Type  malfunction  
Manufacturer Narrative
The following elements have blank data.
 
Event Description
Patient was admitted for replacement/revision of inflatable penile prosthesis that was implanted approximately five years ago.Last year, surgeon reports the device was not working well and approximately four months ago this year, the device was not functioning at all.Patient was able to achieve erection, but immediately subsides after pumping the inflatable penile prosthesis.Surgeon noted appearance of fluid on exam and this is consistent with a nonfunctioning lockout valve.Device was removed and replaced with ams implanted device.Patient had no post-op complications and was discharged home the day after surgery.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS
Type of Device
PENILE PROSTHESIS
Manufacturer (Section D)
AMERICAN MEDICAL SYSTEMS INC
10700 bren road west
minnetonka MN 55343
MDR Report Key5009792
MDR Text Key23228837
Report Number5009792
Device Sequence Number1
Product Code JCW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Report Date 08/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2015
Is this an Adverse Event Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/11/2015
Device Age5 YR
Event Location Hospital
Date Report to Manufacturer08/11/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age79 YR
Patient Weight76
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