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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 72401452
Device Problem Mechanical Problem (1384)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 12/01/2018
Event Type  Injury  
Manufacturer Narrative
Event date is an estimate.Device not returned for evaluation.
 
Event Description
It was reported that due to a defect in pumping which included "bleeding through the urethral canal" the patient will his ambicor penile prosthesis (app) revised.It was noted that the issues started in december 2018 and has been "steadily" worsening everyday.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
10700 bren road west
minnetonka MN 66343
Manufacturer Contact
alyson harris
10700 bren road w
minnetonka, MN 55343
4089353452
MDR Report Key9547641
MDR Text Key176011319
Report Number2183959-2019-68468
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953000961
UDI-Public00878953000961
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 01/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/28/2015
Device Model Number72401452
Device Catalogue Number72401452
Device Lot Number659535003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/30/2010
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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