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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404252
Device Problems Fluid Leak; Mechanical Problem; Material Puncture / Hole; Free or Unrestricted Flow
Event Date 08/17/2019
Event Type  Injury  
Manufacturer Narrative

Additional product component: model number/catalog number 720185-01, serial number: null, batch/lot number 734350011, model/catalog description reservoir flat iz 100 ml.

 
Event Description

It was reported that the patient experienced mechanical issues with an inflatable penile prosthesis (ipp) due to it deflating too quickly during use. The patient also stated that the issue began about a month ago. A replacement surgery was performed in which the existing device was explanted and a new ipp was implanted. During the procedure fluid leak was identified due to a hole in the reservoir tubing. All the ipp components were sent to pathology. The patient was said to be good after the procedure.

 
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Brand NameAMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
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 Key9163757
Report Number2183959-2019-66682
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/07/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/07/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/13/2012
Device MODEL Number72404252
Device Catalogue Number72404252
Device LOT Number683323005
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/29/2010
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: 10/07/2019 Patient Sequence Number: 1
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