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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 Deflation Problem (1149)
Patient Problems Hematoma (1884); Pain (1994); Perforation of Vessels (2135)
Event Date 09/01/2023
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 following the inflatable penile prosthesis implant procedure, he developed a significant hematoma due to a severed blood vessel in the scrotum.Following surgery, the penis was left in an erect state.At the 6-week post op appointment, the physician was unable to deflate the device as the patient was too sore.The patient was seen again with the same results.The patient scheduled a follow up appointment with a different physician for evaluation.Proper deflation techniques 'were discussed with the manufacturer's representative.The patient will attempt the suggested techniques.It was suggested that the patient attempt to obtain an earlier appointment or go to er if his pain/discomfort changes.No further patient complications were 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 Key18322991
MDR Text Key330428044
Report Number2124215-2023-70513
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 Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 12/13/2023
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 Health Professional
Device Model Number72404233-12
Device Catalogue Number72404233-12
Device Lot Number1100294022
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/28/2023
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 1100311976
Patient Outcome(s) Required Intervention;
Patient Age85 YR
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