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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, LLC AMS 700; PROSTHESIS, PENIS, INFLATABLE

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AMERICAN MEDICAL SYSTEMS, LLC AMS 700; PROSTHESIS, PENIS, INFLATABLE Back to Search Results
Model Number UNKNKOWN
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Failure of Implant (1924)
Event Date 08/12/2016
Event Type  malfunction  
Event Description
The penile prosthesis that had been originally implanted in 2002 had failed.The patient was taken to the main operating room for explanting of the malfunctioning penile prosthesis and replacement with a new coloplast surgical (titan) penile prosthesis.
 
Manufacturer Narrative
The following elements have blank data.Unique device identifier (udi): for type of device: prosthesis, penis, inflatable.Device serial #: for type of device: prosthesis, penis, inflatable.Device model #: for type of device: prosthesis, penis, inflatable.Device lot #: for type of device: prosthesis, penis, inflatable.Device catalog (ref) #: for type of device: prosthesis, penis, inflatable.
 
Event Description
The penile prosthesis that had been originally implanted in 2002 had failed.The patient was taken to the main or for explanting of the malfunctioning penile prosthesis and replacement with a new coloplast surgical (titan) penile prosthesis.
 
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Brand Name
AMS 700
Type of Device
PROSTHESIS, PENIS, INFLATABLE
Manufacturer (Section D)
AMERICAN MEDICAL SYSTEMS, LLC
10700 bren road west
minnetonka MN 55343
MDR Report Key5982794
MDR Text Key55792664
Report Number5982794
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,Followup
Report Date 09/06/2016,09/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberUNKNKOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/06/2016
Device Age14 YR
Event Location Hospital
Date Report to Manufacturer09/06/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/28/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/18/2017
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 Age70 YR
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