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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 UNK-P-IPP
Device Problems Inflation Problem (1310); Labelling, Instructions for Use or Training Problem (1318)
Patient Problem Swelling (2091)
Event Date 11/01/2018
Event Type  Malfunction  
Event Description

It was reported that the patient experienced auto-inflation with their inflatable penile prosthesis since implant. The device would partially inflate after deflation. The auto-inflation was due to the patient not compressing the pump hard enough to set the valve. The patient's post-operative swelling also added to the appearance of auto-inflation. The issue will resolve over time. Boston scientific has been unable obtain additional information regarding the circumstances surrounding this event to date. Should additional relevant details become available a supplemental report will be submitted.

 
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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
mike bocchino
10700 bren road w
minnetonka, MN 55343
6515827161
MDR Report Key8122993
MDR Text Key129029859
Report Number2183959-2018-61305
Device Sequence Number1
Product Code FHW
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Type of Report Initial
Report Date 12/01/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/01/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberUNK-P-IPP
Device Catalogue NumberUNK-P-IPP
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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