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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: (AMS) AMERICAN MEDICAL SYSTEMS, INC. AMS 700 MS SERIES PENILE PROSTHESIS
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(AMS) AMERICAN MEDICAL SYSTEMS, INC. AMS 700 MS SERIES PENILE PROSTHESIS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Rash (2033); Inadequate Pain Relief (2388); Weight Changes (2607)
Event Date 06/15/2014
Event Type  Injury  
Event Description
Implant - severe rash in genital area and pain.Medication - weight gain (obese), erectile dysfunction.Have been taking prozac and risperdal for 15 year (starting in 1995).Through the years, have much weight gain due to medication.Due to erectile dysfunction, i had surgery to put in the ams 700 ms series.Penile implant.I have genital pain and get a severe rash.Have to use prescription cream, as needed for rash.Surgery was (b)(6) 2014.I still have pain and get the rashes.When started medication prozac (brand name) than years later, the generic name was used to present (fluoxetine hcl), i have to continue to take because it works for my mental health and there is no other medication yet.The risperdal was stopped by the doctor.I still have the ams 700 ms series penile prosthesis, but i can't use it.It is not working right and is too short.Still have pain and get severe rash.Please can you recommend a lawyer.Did the problem stop after the person reduced the dose or stopped taking or using the product? yes.
 
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Brand Name
AMS 700 MS SERIES PENILE PROSTHESIS
Type of Device
AMS 700 MS SERIES PENILE PROSTHESIS
Manufacturer (Section D)
(AMS) AMERICAN MEDICAL SYSTEMS, INC.
MDR Report Key5256769
MDR Text Key32414211
Report NumberMW5058183
Device Sequence Number1
Product Code FAE
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/25/2015
Type of Device Usage N
Patient Sequence Number1
Treatment
LIPITOR
Patient Outcome(s) Other;
Patient Age61 YR
Patient Weight138
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