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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 72401453
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Erosion (1750); Pain (1994)
Date of Event 01/14/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient underwent a surgical procedure to revise this ambicor penile prosthesis (app) due to pain.The physician observed the device was eroding out of the penis.The app was explanted and no new device was implanted.The patient fully recovered following the procedure.
 
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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 Key11282610
Report Number2183959-2021-00305
Device Sequence Number14510149
Product Code FHW
UDI-Device Identifier00878953000978
UDI-Public00878953000978
Combination Product (Y/N)N
Initial Reporter StateLA
Initial Reporter CountryUS
PMA/510(K) Number
N970012
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/04/2021
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 Date05/13/2015
Device Model Number72401453
Device Catalogue Number72401453
Device Lot Number652990003
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/14/2021
Initial Report FDA Received Date02/04/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age83 YR
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