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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 72401457
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/17/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient underwent an ambicor penile prosthesis (app) surgery due to there was a leak in the right cylinder.The app device was replaced with a new 15.5 mm app.No patient complications were reported in relation to his event.No more information is available at the moment, additional information will be provided as relevant information becomes available.
 
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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 Key9289608
Report Number2183959-2019-67331
Device Sequence Number16670345
Product Code FHW
UDI-Device Identifier00878953001012
UDI-Public00878953001012
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
N970012
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/07/2019
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 Date10/22/2018
Device Model Number72401457
Device Catalogue Number72401457
Device Lot Number852866001
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/17/2019
Initial Report FDA Received Date11/07/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age74 YR
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