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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 10/01/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Model number: 720182-01, lot number: 0128800001, model description: reservoir flat 100 ml.(b)(4).
 
Event or Problem Description
It was reported that the inflatable penile prosthesis (ipp) has broken.The ipp will be revised as the patient is in a wheelchair and the physician believes he may have "serious complications if he does not have an implant exchange." further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.
 
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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 Key8108974
Report Number2183959-2018-61174
Device Sequence Number1900716
Product Code FHW
UDI-Device Identifier00878953003481
UDI-Public00878953003481
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
N970012
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date02/17/2019
Device Model Number72404235
Device Catalogue Number72404235
Device Lot Number0165257009
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/30/2018
Initial Report FDA Received Date11/27/2018
Patient Sequence Number1
Patient Age49 YR
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