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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 Problems Collapse; Mechanical Problem
Event Date 01/02/2020
Event Type  Injury  
Manufacturer Narrative

Device not returned for evaluation.

 
Event Description

It was reported that due to a right connector disorder the patient had his inflatable penile prosthesis (ipp) pump removed and replaced. It was also included that there was a "pump connection tube failure. " additional information was received that the pump bulb stayed flat when pressing the bulb. This occurred two weeks ahead of surgery and the patient got well after this surgery.

 
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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 Key9624158
Report Number2183959-2020-00224
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/25/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/23/2020
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 Number127730005
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/31/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/07/2016
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: 01/23/2020 Patient Sequence Number: 1
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