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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 72404310
Device Problem Collapse (1099)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/26/2020
Event Type  Injury  
Event Description

It was reported that the patient experienced a replacement of an inflatable penile prosthesis (ipp) pump due to the pump staying flat when pressed. A patient outcome of stable was reported.

 
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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 west
minnetonka MN 55343
Manufacturer Contact
alyson harris
10700 bren road w
minnetonka, MN 55343
4089353452
MDR Report Key10182656
MDR Text Key196057235
Report Number2183959-2020-02630
Device Sequence Number1
Product Code FHW
Combination Product (Y/N)N
Reporter Country CodeKS
PMA/PMN NumberN970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number72404310
Device Catalogue Number72404310
Device LOT Number1000206081
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/22/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/20/2018
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: 06/23/2020 Patient Sequence Number: 1
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