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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404258
Device Problems Collapse; Fluid Leak; Noise, Audible
Event Date 09/01/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Reservoir flat iz 100 ml. Device impotence mechanical/hydraulic.

 
Event Description

It was reported that patient liaison spoke with the patient regarding his inflatable penile prosthesis (ipp). He states that over the past few weeks when he pushes the deflate button in, it stays depressed. He also states that when he does pump his device he feels a squishing noise and does not get a full erection. Patient suspects that there is a leak within the system. Patient liaison did go over the reboot/reset maneuver with him to reset the valve if possible. He is going to try that and if he does not have success, he is going to make an appointment with the surgeon. Patient asked about warranty and patient liaison gave him the warranty process. He stated that in the past, the surgeon told him that if the device did not work for him that he would only replace the pump. Patient liaison did review with the patient that changing the entire device would be prudent and that it would be returned for analysis. He also stated that the surgeon suggested the two piece if he had trouble with the three piece. Patient liaison let him know that he could discuss with his doctor the possibility of having the three piece device reimplanted.

 
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Brand NameAMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
Type of DeviceDEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
Manufacturer Contact
alyson harris
10700 bren road w
minnetonka , MN 55343
4089353452
MDR Report Key9145504
Report Number2183959-2019-66450
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 10/02/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/02/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/27/2020
Device MODEL Number72404258
Device Catalogue Number72404258
Device LOT Number1000080156
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/28/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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