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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 Problem Collapse (1099)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2019
Event Type  Injury  
Event Description
It was reported that the patient had the inflatable penile prosthesis pump component removed due to a 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 there was no specific cause of the dimpled pump.
 
Event Description
It was reported that the patient had the inflatable penile prosthesis pump component removed due to a 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 there was no specific cause of the dimpled pump.
 
Manufacturer Narrative
The ams 700 momentary squeeze (ms) pump was visually inspected; no leaks were found.The pump was functionally tested and performed within specification.Device analysis was unable to confirm a device 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 Key9481967
MDR Text Key171629340
Report Number2183959-2019-68188
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 02/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/15/2023
Device Model Number72404310
Device Catalogue Number72404310
Device Lot Number1000193357
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2020
Date Manufacturer Received01/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age59 MO
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