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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404231
Device Problems Collapse; Fluid Leak; Inflation Problem
Event Date 05/28/2019
Event Type  Injury  
Manufacturer Narrative

Medical device: model number/catalog number 720185-01, serial number (b)(4), batch/lot number 151513011, gtin (b)(4), description reservoir flat iz 100 ml, expiration date 09/29/2018, medical device: manufacturer date 10/19/2016.

 
Event Description

It was reported that the patient had the inflatable penile prosthesis removed due to the right cylinder failing to inflate properly upon activation. When activated, the pump also appeared misshapen within the patients scrotum. The reservoir was found during the procedure to contain significantly less fluid than it had been filled with. A new inflatable penile prosthesis consisting of cylinders, pump, and reservoir were implanted. Additional information received indicated that the leak was unknown at time of surgery, all that was found was that there was only a small volume of saline left in the system and that the pump was depressed when the device was activated.

 
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Brand NameAMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
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 Key8727471
Report Number2183959-2019-64509
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/24/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/20/2018
Device MODEL Number72404231
Device Catalogue Number72404231
Device LOT Number0130935004
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/13/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/20/2016
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: 06/24/2019 Patient Sequence Number: 1
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