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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 Problem Collapse
Event Date 09/23/2019
Event Type  Malfunction  
Event Description

It was reported that the patient had his prostate removed due to cancer. The surgery left him unable to perform sexually. The patient opted to have implanted an inflatable penile prosthesis (ipp). The ipp worked fine for two years and a half until the pump failed. The patient is upset and is requesting to be economically compensated to have his device replaced due to it did not lasted the normal life expectancy. A new prosthesis will be implanted on (b)(6) 2019. No more information is available at the moment, additional information was requested and will be provided as relevant information becomes available.

 
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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 Key9180272
Report Number2183959-2019-66759
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 10/09/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/11/2019
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
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2019
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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