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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 72404013
Device Problem Difficult to Insert
Event Date 03/08/2019
Event Type  Injury  
Event Description

It was reported that the inflatable penile prosthesis (ipp) cylinders were explanted due to "difficulty of access to proximal corpus at the previous surgery. " a new pair of 14cm x 9. 5mm ipp cylinders were implanted. It was further reported that no further patient complications were reported. Product was explanted and expected to be returned. A supplemental report will be filed after product has been returned and product analysis has been completed.

 
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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 Key8509434
Report Number2183959-2019-62198
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/13/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/12/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number72404013
Device Catalogue Number72404013
Device LOT Number1000111948
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/15/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/24/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/12/2019 Patient Sequence Number: 1
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