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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
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AMERICAN MEDICAL SYSTEMS, INC. AMS SPECTRA CONCEALABLE PENILE PROSTHESIS Back to Search Results
Catalog Number 720074-02
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 08/15/2013
Event Type  Injury  
Manufacturer Narrative
Should additional information become available regarding this event it will be re-evaluated and a follow-up report will be sent.
 
Event Description
It was reported that the patient had his device removed due to infection. Patient was implanted with an inflatable penile prosthesis at the same procedure. No additional patient complications were reported in relation to this event.
 
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Brand NameAMS SPECTRA CONCEALABLE PENILE PROSTHESIS
Type of DevicePENILE PROSTHESIS
Manufacturer (Section D)
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren road west
minnetonka MN 55343
Manufacturer Contact
sharon zurn, director
10700 bren rd., west
minnetonka, MN 55343
9529306347
MDR Report Key3373129
MDR Text Key11115209
Report Number2183959-2013-01029
Device Sequence Number1
Product Code FAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 09/06/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/08/2017
Device Catalogue Number720074-02
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/06/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/23/2013 Patient Sequence Number: 1
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