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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS AMBICOR PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS AMBICOR PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72401450
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Fever (1858); Unspecified Infection (1930); Pain (1994)
Date of Event 04/15/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient underwent surgical procedure to revise this ambicor penile prosthesis (app) due to an infection, fever, and local pain.The app was explanted and replaced with a new app.Following the procedure the patient was ok.
 
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Brand Name
AMS AMBICOR PENILE PROSTHESIS
Common Device Name
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key11841316
Report Number2124215-2021-14105
Device Sequence Number11018225
Product Code FHW
UDI-Device Identifier00878953000947
UDI-Public00878953000947
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
N970012
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source foreign,health professional,o
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/18/2021
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? No
Operator of Device Lay User/Patient
Device Expiration Date02/07/2022
Device Model Number72401450
Device Catalogue Number72401450
Device Lot Number0163698002
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/13/2021
Initial Report FDA Received Date05/18/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age70 YR
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