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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 72404256
Device Problems Collapse (1099); Fluid/Blood Leak (1250); Inflation Problem (1310); Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/28/2023
Event Type  Injury  
Event Description
It was reported that the patient underwent an inflatable penile prosthesis replacement surgery due to inflation issues and the pump staying flat.Upon explant, air in the system and a total fluid loss was noted, but its source and location could not be identified, therefore, all components were removed and replaced.There were no patient complications reported.
 
Manufacturer Narrative
The implant date, lot number, manufacture date and expiration date were unable to be obtained through good faith efforts.The data was obtained through a review of the surgical history previously provided by the physician.
 
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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
john stoffregen
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key17343566
MDR Text Key319235164
Report Number2124215-2023-37849
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003641
UDI-Public00878953003641
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 07/18/2023
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 Lay User/Patient
Device Expiration Date04/23/2017
Device Model Number72404256
Device Catalogue Number72404256
Device Lot Number932646003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/28/2023
Initial Date FDA Received07/18/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/13/2015
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: 72404155 / LOT: 937848010
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age71 YR
Patient SexMale
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