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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 72404237
Device Problems Tube (525); Fluid Leak (1250); Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2018
Event Type  Injury  
Event Description

It was reported that the patient experienced fluid loss with inflatable penile prosthesis (ipp) due to tear in the outer silicone tube of the left cylinder. The original reservoir was drained and retained and a new ipp was implanted. Further information was requested and not yet received. Should additional relevant details become available, a supplemental report will be submitted.

 
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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 bocchino
10700 bren road w
,
minnetonka, MN 55343
4089353452
MDR Report Key8047216
MDR Text Key126499577
Report Number2183959-2018-60709
Device Sequence Number1
Product Code FHW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberN970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/13/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/08/2015
Device MODEL Number72404237
Device Catalogue Number72404237
Device LOT Number807326004
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/24/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/09/2011
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: 11/07/2018 Patient Sequence Number: 1
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