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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS INC AMS UNKNOWN MODEL; PROSTHESIS, PENIS, INFLATABLE
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AMERICAN MEDICAL SYSTEMS INC AMS UNKNOWN MODEL; PROSTHESIS, PENIS, INFLATABLE Back to Search Results
Device Problem Leak/Splash (1354)
Patient Problem No Code Available (3191)
Event Date 12/13/2017
Event Type  malfunction  
Event Description
Patient had placement of an ams inflatable penile prosthesis approximately 9 years ago that has quit working due to a tubing leak.Patient was taken to surgery for surgical explant of the malfunctioning internal penile pump (ipp) device and replacement with another ams inflatable penile prosthesis.Patient tolerated the procedure well with no complications and was discharged home.Manufacturer response: for inflatable penile prosthesis (per site reporter).Manufacturer will investigate the cause of the malfunction upon receipt of the device.
 
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Brand Name
AMS UNKNOWN MODEL
Type of Device
PROSTHESIS, PENIS, INFLATABLE
Manufacturer (Section D)
AMERICAN MEDICAL SYSTEMS INC
10700 bren road west
minnetonka MN 55343
MDR Report Key7150565
MDR Text Key95934168
Report Number7150565
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
Type of Report Initial
Report Date 12/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem 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 FDA12/21/2017
Device Age9 YR
Event Location Hospital
Date Report to Manufacturer12/21/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/28/2017
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 Age65 YR
Patient Weight114
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