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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 Malposition of Device (2616)
Patient Problems Scarring (2061); Discomfort (2330)
Event Date 06/12/2020
Event Type  Injury  
Event Description
It was reported that patient experienced discomfort after placement of inflatable penile prosthesis (ipp).Physician exam the device and determine potential cross over.During revision surgery it was determined the cylinder was not positioned correctly.The physician dilated through some fibrous scar tissue and repositioned the cylinder to the correct location.
 
Manufacturer Narrative
Field change: h6.
 
Event Description
It was reported that patient experienced discomfort after placement of inflatable penile prosthesis (ipp).Physician exam the device and determine potential cross over.During revision surgery it was determined the cylinder was not positioned correctly.The physician dilated through some fibrous scar tissue and repositioned the cylinder to the correct location.
 
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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 Key10228463
MDR Text Key197565604
Report Number2183959-2020-02799
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 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/28/2021
Device Model Number72404252-10
Device Catalogue Number72404252-10
Device Lot Number1000281912
Was Device Available for Evaluation? No
Date Manufacturer Received07/09/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age62 YR
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