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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 72404252-10
Device Problem Inflation Problem (1310)
Patient Problems Capsular Contracture (1761); No Consequences Or Impact To Patient (2199)
Event Date 11/27/2019
Event Type  Injury  
Event Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) procedure due to unknown reason.The previous pump was removed and replaced.No information about the patient's outcome was provided.No more information is available at the moment.Additional information received.The patient complained of a sticky pump as he was having difficulties pumping the device shortly after implantation.The patient had a good outcome after revision procedure.
 
Event Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) procedure due to unknown reason.The previous pump was removed and replaced.No information about the patient's outcome was provided.No more information is available at the moment.Additional information received.The patient complained of a sticky pump as he was having difficulties pumping the device shortly after implantation.The patient had a good outcome after revision procedure.
 
Manufacturer Narrative
The complaint component was returned and analyzed, and the reported allegation was not confirmed via product analysis.Visual and functional testing were completed; the pump performed within specification.Product analysis was unable to confirm a pump malfunction nor the allegation related to capsular contracture.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
Type of Device
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key9521879
MDR Text Key173445116
Report Number2183959-2019-68325
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953009810
UDI-Public00878953009810
Combination Product (y/n)N
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number72404252-10
Device Catalogue Number72404252-10
Device Lot Number1000318893
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2020
Initial Date Manufacturer Received 12/02/2019
Initial Date FDA Received12/26/2019
Supplement Dates Manufacturer Received01/20/2020
Supplement Dates FDA Received02/10/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age76 YR
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