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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 72404013
Device Problem Inflation Problem (1310)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/02/2019
Event Type  Injury  
Event Description
It was reported that the patient had the inflatable penile prosthesis left cylinder and pump components removed due to an inflation problem.Pump was replaced with cxm pump retained by hospital, so they didn't use a new pump.Additional information received indicated the patient had a difficulty to inflate the device.
 
Manufacturer Narrative
D10, h3, h6, h10.H3 device evaluation: the ams700 ipp cylinder was visually inspected and functionally tested; no leaks were found.The cylinder performed within specification.The allegation related to an inflation issue could not be confirmed.
 
Event Description
It was reported that the patient had the inflatable penile prosthesis left cylinder and pump components removed due to an inflation problem.Pump was replaced with cxm pump retained by hospital, so they didn't use a new pump.Additional information received indicated the patient had a difficulty to inflate the device.
 
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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 Key9517750
MDR Text Key172696233
Report Number2183959-2019-68312
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953002705
UDI-Public00878953002705
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 02/13/2020
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 Date12/05/2023
Device Model Number72404013
Device Catalogue Number72404013
Device Lot Number1000196975
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2020
Initial Date Manufacturer Received 12/02/2019
Initial Date FDA Received12/25/2019
Supplement Dates Manufacturer Received01/29/2020
Supplement Dates FDA Received02/13/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age61 YR
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