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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404011
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/28/2020
Event Type  malfunction  
Event Description
It was reported that a patient that had leukemia, a blood disease problem which caused the penis to be abnormally erect and severe penile fibrosis underwent an inflatable penile prosthesis (ipp) implant.However, after installation the device could not be used, leading to the ipp being removed and no new device was implanted during the same procedure.The physician noted that the patient fibrosis and dead space conditions caused the patient to fail getting good results with the procedure.There were no patient complications reported and the patient was said to be stable following the procedure.
 
Manufacturer Narrative
Product investigation completed.The cylinders were visually inspected and functionally tested; no leaks were found.The cylinders were pressure tested and performed within specification.Product analysis was unable to confirm the reported event.Based on the results of this investigation, no escalation is required.
 
Event Description
It was reported that a patient that had leukemia, a blood disease problem which caused the penis to be abnormally erect and severe penile fibrosis underwent an inflatable penile prosthesis (ipp) implant.However, after installation the device could not be used, leading to the ipp being removed and no new device was implanted during the same procedure.The physician noted that the patient fibrosis and dead space conditions caused the patient to fail getting good results with the procedure.There were no patient complications reported and the patient was said to be stable following the procedure.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS
Type of Device
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key11152024
MDR Text Key226223942
Report Number2183959-2020-06362
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953002682
UDI-Public00878953002682
Combination Product (y/n)N
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/24/2022
Device Model Number72404011
Device Catalogue Number72404011
Device Lot Number0182561009
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2021
Date Manufacturer Received01/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age28 YR
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