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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 72404237
Device Problem Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2024
Event Type  Injury  
Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.
 
Event Description
It was reported that the patient presented with an inflatable penile prosthesis (ipp) pump that was riding high in the patient's scrotum.The physician suspects that the migration of the pump was due to the patient's anatomy and the patient not pulling down on the pump as instructed.An incision was made in the scrotum, the old pump was removed, and a new space was made for a new ipp pump.The new pump was connected to the original device with quick connectors.There were no patient complications reported.
 
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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 Key18616369
MDR Text Key334226194
Report Number2124215-2024-04958
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003504
UDI-Public00878953003504
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
Report Date 01/31/2024
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
Device Operator Lay User/Patient
Device Model Number72404237
Device Catalogue Number72404237
Device Lot Number1100353356
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/12/2024
Initial Date FDA Received01/31/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2023
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#: 1100357134
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age71 YR
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