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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 72401455
Device Problems Deflation Problem (1149); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Erosion (1750)
Event Date 07/07/2020
Event Type  Injury  
Event Description
It was reported that the patient underwent a revision procedure due to erosion, and the inability to deflate the device resulting in a consistent erection with an ambicor penile prosthesis (app).The app was explanted and a new app was implanted.The patient was 'ok' following the procedure.
 
Manufacturer Narrative
Device analysis: product analysis was unable to confirm the reported related to erosion; however, a bulge was identified in one of cylinders along with broken fabric treads.This cylinder bulging due to broken fabric treads would directly affect the overall functionality of the device and is therefore product analysis concluded the identified bulge in one of cylinders confirmed the reported allegation of device deflation issue.
 
Event Description
It was reported that the patient underwent a revision procedure due to erosion, and the inability to deflate the device resulting in a consistent erection with an ambicor penile prosthesis (app).The app was explanted and a new app was implanted.The patient was 'ok' following the procedure.
 
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Brand Name
AMS AMBICOR PENILE PROSTHESIS
Type of Device
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key10369978
MDR Text Key201764670
Report Number2183959-2020-03359
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953000992
UDI-Public00878953000992
Combination Product (y/n)N
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 09/09/2020
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
Device Operator Lay User/Patient
Device Expiration Date01/17/2016
Device Model Number72401455
Device Catalogue Number72401455
Device Lot Number692182005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2020
Initial Date Manufacturer Received 07/16/2020
Initial Date FDA Received08/05/2020
Supplement Dates Manufacturer Received08/14/2020
Supplement Dates FDA Received09/09/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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