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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS, PENILE
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AMERICAN MEDICAL SYSTEMS (MN) AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS, PENILE Back to Search Results
Catalog Number 720074-03
Device Problem Extrusion (2934)
Patient Problem Discomfort (2330)
Event Type  Injury  
Event Description
It was reported the patient will have his spectra penile prosthesis revised due to cylinder extrusion and discomfort.No additional patient complications were reported in relation to this event.
 
Manufacturer Narrative
The spectra cylinders were visually inspected and functionally tested.They performed within specifications.
 
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Brand Name
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
Type of Device
PROSTHESIS, PENILE
Manufacturer (Section D)
AMERICAN MEDICAL SYSTEMS (MN)
10700 bren road w
minnetonka MN 55343
Manufacturer (Section G)
AMERICAN MEDICAL SYSTEMS (MN)
10700 bren road w
minnetonka MN 55343
Manufacturer Contact
sharon zurn
10700 bren road w
minnetonka, MN 55343
9529306000
MDR Report Key5607524
MDR Text Key43616057
Report Number2183959-2016-00111
Device Sequence Number1
Product Code FAE
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/28/2018
Device Catalogue Number720074-03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/23/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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