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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 72404233-12
Device Problem Labelling, Instructions for Use or Training Problem (1318)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/09/2020
Event Type  Malfunction  
Event Description

It was reported that the patient describes he has difficulty with first pump and move the lock out valve to allow fluid transfer to the cylinders of his inflatable penile prosthesis (ipp). After multiple attempts he is able to inflate the device completely. Patient was advised to fill cylinders daily (he is currently only doing this occasionally). Also advised to squeeze block of pump if having difficulty as well as alternate pump, squeezing block and pushing deflate button in an attempt to lubricate the valve. No further complications. Patient will notify of status in a couple weeks. Additional information received. This is possibly a device education issue. A product malfunction has not been confirmed.

 
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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 Key9628417
MDR Text Key176287891
Report Number2183959-2020-00232
Device Sequence Number1
Product Code FHW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberN970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 01/24/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/24/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number72404233-12
Device Catalogue Number72404233-12
Device LOT Number1000222489
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/31/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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