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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST CORP., / AMERICAN MEDICAL SYSTEMS INC. COLOPLAST TITAN OTR. A/S - AMS 700 MS SERIES PENILE PROSTHESIS
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COLOPLAST CORP., / AMERICAN MEDICAL SYSTEMS INC. COLOPLAST TITAN OTR. A/S - AMS 700 MS SERIES PENILE PROSTHESIS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Irritation (1941); Pain (1994); Tissue Damage (2104); Weakness (2145); Discomfort (2330)
Event Type  Other  
Event Description
These devices have caused me nothing but pain since they were implanted.They have never helped me with my erectile dysfunction problem and have caused me other medical problems.I hope that these two medical forms i am sending to you can better explain my situation.Assessment: s/p inflatable penile prosthesis insertion (b)(6) 2014.Incisions are healing well, prosthesis tested but still tender.Irritation regarding chafing of right scrotum against right thigh.Complains of left leg weakness - cause unk.Plan: invest in jockey style briefs to eliminate friction and chafing.Oxycodone for residual pain.Return to office in 6 weeks to review use of the inflatable penile prosthesis including deflation.Recommend that your spouse comes to that visit.If symptoms worsen or new urologic symptoms arise, contact office for an earlier return appointment if indicated.
 
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Brand Name
COLOPLAST TITAN OTR. A/S - AMS 700 MS SERIES PENILE PROSTHESIS
Type of Device
COLOPLAST TITAN OTR. A/S - AMS 700 MS SERIES PENILE PROSTHESIS
Manufacturer (Section D)
COLOPLAST CORP., / AMERICAN MEDICAL SYSTEMS INC.
minneapolis MN
MDR Report Key5853010
MDR Text Key51775208
Report NumberMW5063882
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 07/25/2016
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? No
Device Operator No Information
Other Device ID Number600659-01A(04/10)M1786N
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/04/2016
Type of Device Usage N
Patient Sequence Number1
Patient Age70 YR
Patient Weight84
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