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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 72404251
Device Problems Collapse; Defective Device
Event Date 10/26/2016
Event Type  Malfunction  
Manufacturer Narrative

Model number/catalog number: 720185-01, serial number null batch/lot number: (b)(4), model/catalog description: reservoir flat iz 100 ml.

 
Event Description

It was reported that the patient stated experiencing pain for the past three years with an inflatable penile prosthesis (ipp). The patient also indicated that when trying to activate the device the pump "went flat" and would not refill even after pushing the deflate button. The patient also expressed dissatisfaction with the ipp as it has "at least 25 defects in design". The patient scheduled an assessment appointment with the physician and said would contact patient liaison after the appointment. The patient also stated the possibility of hiring an attorney if the ipp was found to be defective to try and get compensation. Product performance analyst (ppa) was unable to request further information, as customer contact for the account is unknown. No more information available at the moment. Should additional information become available, it will be provided.

 
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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
4083953452
MDR Report Key8843294
Report Number2183959-2019-65396
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type CONSUMER
Type of Report Initial
Report Date 07/30/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/30/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/20/2018
Device MODEL Number72404251
Device Catalogue Number72404251
Device LOT Number0150055004
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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