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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 Inflation Problem; Loose or Intermittent Connection
Event Date 12/03/2019
Event Type  Injury  
Event Description

It was reported that the patient underwent a revision procedure due to left cylinder connector disorder with an inflatable penile prosthesis (ipp). The ipp pump was explanted and a new ipp pump was implanted. Additional information was reported that the patient presented with inflation issues two weeks prior to revision procedure at the junction of the left cylinder. The patient recovered post 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)
AMERICAN MEDICAL SYSTEMS LLC
10700 bren road west
minnetonka MN 55343
Manufacturer Contact
alyson harris
10700 bren road w
minnetonka , MN 55343
4089353452
MDR Report Key9484138
Report Number2183959-2019-68202
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2019
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 Number0176308007
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/21/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/30/2017
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: 12/17/2019 Patient Sequence Number: 1
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