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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 Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 04/12/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the ambicor penile prosthesis (app) device had fluid loss.The patient underwent a surgical procedure in which his app was explanted and a new inflatable penile prosthesis (ipp) was implanted.The patient remains stable after 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
300 boston scientific way
marlborough MA 01752
MDR Report Key11867462
Report Number2124215-2021-14535
Device Sequence Number17254154
Product Code FHW
UDI-Device Identifier00878953000947
UDI-Public00878953000947
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
N970012
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
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) 05/21/2021
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? Yes
Operator of Device Lay User/Patient
Device Expiration Date07/23/2018
Device Model Number72401450
Device Catalogue Number72401450
Device Lot Number840432005
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/30/2021
Initial Report FDA Received Date05/21/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age50 YR
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