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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MINNETONKA AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC Back to Search Results
Catalog Number 72404251
Device Problems Cylinder; Reservoir; Break; Fluid Leak; Material Rupture
Event Date 06/25/2018
Event Type  Injury  
Manufacturer Narrative

Catalog #: 72402970. Serial #: (b)(4), expiration date: 4/27/2012.

 
Event Description

It was reported that the inflatable penile prosthesis was replaced due to "signs of rupture of the inflatable prosthesis reservoir. " it was found that there was a loss of fluid and the cylinders were broken. This complaint was initially submitted to fda via asr report q2 2018 and additional information was received by boston scientific. Due to the removal of exemption e1997037, this information is provided via supplemental report.

 
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Brand NameAMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
Type of DeviceDEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC - MINNETONKA
10700 bren road w
minnetonka MN 55343
Manufacturer (Section G)
BOSTON SCIENTIFIC - MINNETONKA
10700 bren road w
minnetonka MN 55343
Manufacturer Contact
sharon zurn
10700 bren road w
minnetonka , MN 55343
9529306000
MDR Report Key8232950
Report Number2183959-2019-00004
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 06/08/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/10/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/19/2012
Device Catalogue Number72404251
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 Received12/20/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/10/2019 Patient Sequence Number: 1
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