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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 72404310
Device Problems Collapse (1099); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/19/2019
Event Type  Injury  
Event Description
It was reported that the patient had the inflatable penile prosthesis pump component removed due to dimpled pump.A new inflatable penile prosthesis pump component was implanted.The event resolved.Further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.Additional information received indicated the specific cause of the dimpled pump was not found.
 
Event Description
It was reported that the patient had the inflatable penile prosthesis pump component removed due to dimpled pump.A new inflatable penile prosthesis pump component was implanted.The event resolved.Further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.Additional information received indicated the specific cause of the dimpled pump was not found.
 
Manufacturer Narrative
Device evaluation: the ams700 momentary squeeze pump was visually inspected and functionally tested.No leak was found.The pump failed the 8 lb.Activation test.The pump required more than 8 lbs.Of force to activate.The product analysis confirmed that there was a pump malfunction.
 
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Brand Name
AMS INFLATABLE PENILE PROSTHESIS
Type of Device
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key9187274
MDR Text Key162442449
Report Number2183959-2019-66813
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003986
UDI-Public00878953003986
Combination Product (y/n)N
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 12/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/19/2023
Device Model Number72404310
Device Catalogue Number72404310
Device Lot Number1000118534
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/24/2019
Date Manufacturer Received11/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age64 YR
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