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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 72404282
Device Problems Collapse (1099); Deflation Problem (1149); Inflation Problem (1310); Defective Device (2588)
Patient Problem Discomfort (2330)
Event Date 04/01/2024
Event Type  Injury  
Event Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced discomfort.An attempt was made to activate the device; however, it was found that the device does not inflate nor deflate being a blockage in the tube between the reservoir and pump the suspected cause.In addition, the pump was reported to stay flat when pressed.A forced deflation maneuver was performed.The device remains implanted, and a revision surgery has not been scheduled.No additional patient complications were reported.
 
Event Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced discomfort.An attempt was made to activate the device; however, it was found that the device does not inflate nor deflate being a blockage in the tube between the reservoir and pump the suspected cause.In addition, the pump was reported to stay flat when pressed.A forced deflation maneuver was performed.The device remains implanted, and a revision surgery has not been scheduled.No additional patient complications were reported.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS
Type of Device
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
farshad fahimi
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key19084557
MDR Text Key339876377
Report Number2124215-2024-20669
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003856
UDI-Public00878953003856
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/10/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number72404282
Device Catalogue Number72404282
Device Lot Number1000529485
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/01/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
RESERVOIR: UPN: 720182-01 / LOT:1100198082; RESERVOIR: UPN: 720182-01 / LOT:1100198082
Patient Outcome(s) Required Intervention; Other; Hospitalization;
Patient Age56 YR
Patient SexMale
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