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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 72404258
Device Problems Failure to Cycle (1142); Inflation Problem (1310)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/13/2020
Event Type  malfunction  
Event Description
It was reported that physician saw patient in the office with complaints of inflatable penile prosthesis (ipp) not working.Physician tried to cycle but it would not inflate.Device was not explanted.
 
Event Description
It was reported that physician saw patient in the office with complaints of inflatable penile prosthesis (ipp) not working.Physician tried to cycle but it would not inflate.Pump and cylinders were explanted and replaced.Reservoir remains on right side.New reservoir was implanted on left side.
 
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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 Key10356500
MDR Text Key201599111
Report Number2183959-2020-03296
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003665
UDI-Public00878953003665
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 10/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/08/2021
Device Model Number72404258
Device Catalogue Number72404258
Device Lot Number1000271963
Was Device Available for Evaluation? No
Date Manufacturer Received09/09/2020
Patient Sequence Number1
Treatment
720185-01/1000256082; 720185-01/1000256082
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age65 YR
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