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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404310
Device Problems Collapse; Mechanical Problem
Event Date 06/21/2019
Event Type  Injury  
Event Description

It was reported that the patient had the inflatable penile prosthesis pump component removed due to disorder. A new inflatable penile prosthesis pump component was implanted. Further information was requested and not yet received. Should additional relevant details become available, a supplemental report will be submitted. Additional information received indicated that when the patient pressed the pump, but the it stayed flat resulting in a dimpled pump. The event occurred 2 weeks ahead of the surgery.

 
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Brand NameAMS INFLATABLE PENILE PROSTHESIS
Type of DeviceDEVICE 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 w
minnetonka MN 55343
Manufacturer Contact
alyson harris
10700 bren road w
minnetonka , MN 55343
4089353452
MDR Report Key8765816
Report Number2183959-2019-64808
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number72404310
Device Catalogue Number72404310
Device LOT Number1000071526
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/14/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/13/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/06/2019 Patient Sequence Number: 1
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