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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 72404236
Device Problem Labelling, Instructions for Use or Training Problem (1318)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/07/2019
Event Type  Malfunction  
Manufacturer Narrative

Related components of device system: model number/ catalog number: 720185-01, serial number: n/a, batch/ lot number: 904948005, model/ catalog description: reservoir flat iz 100 ml.

 
Event Description

It was reported that the patient stated that he is on his second inflatable penile prosthesis (ipp) device in five years and it appears that something has gone wrong with this device as well. The patient stated that when he pumps, the bulb will not refill completely and does not seem to be transferring fluid. The patient reached out to his urologist but the physician was not able to troubleshoot his device. He does not want to have surgery again if possible. The sales representative will contact the patient to find out if this is just a matter of hands on trouble shooting / training. No more information is available at the moment, additional information was requested and will be provided as relevant information becomes available. Additional information received. The sales representative stated that it is believed that this is a device education issue and not a malfunction. Therefore, no surgery is scheduled for this patient at the moment.

 
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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 Key9244232
MDR Text Key164892374
Report Number2183959-2019-67133
Device Sequence Number1
Product Code FHW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberN970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 10/28/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/28/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/12/2016
Device MODEL Number72404236
Device Catalogue Number72404236
Device LOT Number900257004
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/24/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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