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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 72404303
Medical Device Problem Codes Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/22/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the inflatable penile prosthesis (ipp) device had inadequate inflation.All components were explanted and replaced.The patient is doing well.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS
Common Device Name
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key11737456
Report Number2124215-2021-10327
Device Sequence Number3833251
Product Code FHW
UDI-Device Identifier00878953005744
UDI-Public00878953005744
Combination Product (Y/N)N
Initial Reporter CountryCY
PMA/510(K) Number
N970012
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source foreign,health professional,o
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/28/2021
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
Operator of Device Lay User/Patient
Device Expiration Date03/31/2024
Device Model Number72404303
Device Catalogue Number72404303
Device Lot Number1000253252
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/05/2021
Initial Report FDA Received Date04/28/2021
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
RESERVOIRUPN: 72404162LOT: 1000090942
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age65 YR
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