EXTERNAL PENILE RIGIDITY RESPONSE II UNSURE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-02 for EXTERNAL PENILE RIGIDITY RESPONSE II UNSURE manufactured by Augusta Medical Systems.

Event Text Entries

[74542712] I had rarely used my penile pump from (b)(6). Just wasn't that happy with it, etc... In (b)(6) 2016, around (b)(6), i used it, and within the next couple of days, noticed a hard like swollen cord/vein extending the full length of my penis, on the top of it. Also, another swollen hard cord, completely surrounding my penis, just under the glands. Both of these cords, had 2 larger harder bumps in them. First one had one at the base and another one about an inch from the glands; the 2nd hard cord had one on the far left and another on the far right. I worried about this because was concerned it wasn't going to go away or may get worse. Didn't want to seek medical advice because too embarrassing. In fact, didn't tell my wife until after about a month had passed. I had always had some swelling, in the same areas, but it was always minor and dissolved quickly. Never had experienced anything like this before, and i think this would stress out most any male. In (b)(6) 2017, i went to see a urologist about the above, by this time, some of the swelling had gone down, but not all, plus the hard bumps were still there. Dr. Said the lymphatic fluid was having trouble draining because the swollen bumps were clogging up the vessels, and that they should resolve themselves in time, usually about 6 months. I informed him it had already been about that amount of time. I've seen this doctor 3 or 4 times more by (b)(6). Currently, majority of swelling has resolved completely, and the hard bump area, the clotted lymphatic fluid is still there, but can be barely felt. I am afraid to use the penile pump again, concerned it may cause some type of irreversible/permanent damage or more. I personally am surprised these devices are approved by the fda. They are dangerous for use on male penile anatomy, and just like me, there are a lot of men desperately needing and seeking help with erectile dysfunction. When i first received my device, i contacted (b)(6) and reported my concerns about the minor swelling i was having. I was assured that some swelling was completely normal, no, they are dangerous. I've always thought this type of product, can't think of my wording, but that it would have some type of safety that would not allow continuous vacuum pressure. If someone was to continue pumping, and never stop, the vacuum pressure could destroy all veins, vessels, tissue and much more. Why isn't there some safety rule for this. I had read tons of reviews on line and knew never to over pump myself. But what i don't know, was that normal use could cause a penile thrombosis, changes in internal and external penile tissue, tissue veins and vessels, and much more. I had to see a doctor in order to get this device. On the day i went for my doctor's visit, there was a representative from (b)(6) there, named (b)(6). He was also with me during my entire visit with my doctor, along with a third person who was a medical student, s/w embarrassing to say the least. Especially during a prostate exam, just fyi. After the exam, (b)(6) met with me alone, in a separate examining room. He reviewed all important information regarding use and care of the pump, and answered my questions. Another part of this meeting, was to be questioned fitted with the pump, basically just going through the process of applying one, how it feels, looks, and how to remove. I do have problems with my memory, because of a stroke, but i was surprised at him telling me, "most men, after having used the pump for a while, no longer need it, because it helped increased the blood flow to their penis, and now could have normal erections on their own". Because of my stroke, i often carry a voiced activated recorder in my pocket, especially when my wife is not with me in some of my doctors visits, usually just the ones that are totally male related. My wife thought it was odd that (b)(6) stated what i said above. We both felt it was all about making a sale. I hold no hard feelings towards (b)(6), in fact, (b)(6) was a very nice young man.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5069562
MDR Report Key6543714
Date Received2017-05-02
Date of Report2017-05-02
Date of Event2016-09-15
Date Added to Maude2017-05-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameEXTERNAL PENILE RIGIDITY
Generic NameEXTERNAL PENILE RIGIDITY
Product CodeLKY
Date Received2017-05-02
Model NumberRESPONSE II
Catalog NumberUNSURE
Lot NumberUNSURE
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerAUGUSTA MEDICAL SYSTEMS


Patients

Patient NumberTreatmentOutcomeDate
111. Other 2017-05-02

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