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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 72404235
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/12/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient had his previous inflatable penile prosthesis (ipp) removed due to the device was not working, air was observed in the system.A new ipp was implanted.No patient complications were reported in relation to this event.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
Common Device Name
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key10771539
Report Number2183959-2020-05272
Device Sequence Number19670320
Product Code FHW
UDI-Device Identifier00878953003481
UDI-Public00878953003481
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
N970012
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date03/30/2015
Device Model Number72404235
Device Catalogue Number72404235
Device Lot Number822956001
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/12/2020
Initial Report FDA Received Date11/02/2020
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
720185-01/829488016
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age64 YR
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