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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 72404233-12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Purulent Discharge (1812); Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
Event Date 11/09/2023
Event Type  Injury  
Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
 
Event Description
It was reported that a few days after the patient started cycling new inflatable penile prosthesis (ipp) they experienced pain and swelling in their scrotum due to an infection.A pus pocket/scrotal abscess anterior to, but not near, the pump was discovered during the revision procedure.The physician also noted that a vasectomy was performed at the same time as the initial ipp implant.No further patient complications were reported.
 
Event Description
It was reported that a few days after the patient started cycling new inflatable penile prosthesis (ipp) they experienced pain and swelling in their scrotum due to an infection.A pus pocket/scrotal abscess anterior to, but not near, the pump was discovered during the revision procedure.The physician also noted that a vasectomy was performed at the same time as the initial ipp implant.The ipp was removed and a tactra was implanted.After the patient healed, the physician removed the tactra and replaced it with another ipp per the patient request.No further patient complications were reported.
 
Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
 
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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
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 Key18233497
MDR Text Key329314182
Report Number2124215-2023-67526
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953009797
UDI-Public00878953009797
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number72404233-12
Device Catalogue Number72404233-12
Device Lot Number1100304223
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/20/2023
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 720185-01 LOT 1100341937.; RESERVOIR UPN 720185-01 LOT 1100341937.
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age40 YR
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