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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MINNETONKA AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC Back to Search Results
Catalog Number 72404253
Device Problems Tube (525); Break (1069); Fluid Leak (1250); Inflation Problem (1310)
Patient Problem Failure of Implant (1924)
Event Date 05/15/2018
Event Type  Injury  
Manufacturer Narrative

This complaint was initially submitted to fda via asr report q2 2018 and additional information was received by boston scientific. Due to the removal of exemption e1997037, this information is provided via supplemental report. Model number/catalog number 720185-01, serial number (b)(4), batch/lot number 911988004, model/catalog description reservoir, flat, iz, 100 ml, expiration date 11/25/2016. Manufacturer date 12/09/2014.

 
Event Description

It was reported that the patient had difficulty activating their inflatable penile prosthesis. The pump was collapsed. No patient complications reported in relation to this event. Additional information received indicated the device was replaced due to a rupture of the tubing from the pump to the cylinder causing fluid loss.

 
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Brand NameAMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
Type of DeviceDEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC - MINNETONKA
10700 bren road w
minnetonka MN 55343
Manufacturer (Section G)
BOSTON SCIENTIFIC - MINNETONKA
10700 bren road w
minnetonka MN 55343
Manufacturer Contact
sharon zurn
10700 bren road w
minnetonka, MN 55343
9529306000
MDR Report Key8762796
MDR Text Key150108057
Report Number2183959-2019-00026
Device Sequence Number1
Product Code FHW
Combination Product (Y/N)N
Reporter Country CodeBR
PMA/PMN NumberN970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 05/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/04/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/16/2016
Device Catalogue Number72404253
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/05/2014
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: 07/04/2019 Patient Sequence Number: 1
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