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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 72401110
Device Problem Collapse
Event Date 06/07/2019
Event Type  Injury  
Event Description

It was reported that the patient underwent a surgical procedure to replace the pump component of this inflatable penile prosthesis (ipp) as it remained flat upon use. The existing pump was removed and a new pump implanted. There were no patient complications. A supplemental report will be submitted should additional information be received or upon device return and completion of analysis.

 
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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
4083953452
MDR Report Key8713934
Report Number2183959-2019-64299
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/16/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/19/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/26/2017
Device MODEL Number72401110
Device Catalogue Number72401110
Device LOT Number798886004
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/15/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/30/2012
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: 06/19/2019 Patient Sequence Number: 1
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