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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 72404258
Device Problems Collapse (1099); Fluid/Blood Leak (1250); Mechanical Problem (1384); Noise, Audible (3273)
Patient Problem Impotence (1925)
Event Date 09/01/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Reservoir flat iz 100 ml.Device impotence mechanical/hydraulic.
 
Event Description
It was reported that patient liaison spoke with the patient regarding his inflatable penile prosthesis (ipp).He states that over the past few weeks when he pushes the deflate button in, it stays depressed.He also states that when he does pump his device he feels a squishing noise and does not get a full erection.Patient suspects that there is a leak within the system.Patient liaison did go over the reboot/reset maneuver with him to reset the valve if possible.He is going to try that and if he does not have success, he is going to make an appointment with the surgeon.Patient asked about warranty and patient liaison gave him the warranty process.He stated that in the past, the surgeon told him that if the device did not work for him that he would only replace the pump.Patient liaison did review with the patient that changing the entire device would be prudent and that it would be returned for analysis.He also stated that the surgeon suggested the two piece if he had trouble with the three piece.Patient liaison let him know that he could discuss with his doctor the possibility of having the three piece device reimplanted.
 
Manufacturer Narrative
Describe event or problem - updated.(b)(4).Reservoir flat iz 100 ml.Device impotence mechanical/hydraulic.
 
Event Description
It was reported that patient liaison spoke with the patient regarding his inflatable penile prosthesis (ipp).He states that over the past few weeks when he pushes the deflate button in, it stays depressed.He also states that when he does pump his device he feels a squishing noise and does not get a full erection.Patient suspects that there is a leak within the system.Patient experienced initial activation issues with pump at first follow up with physician.Patient liaison did go over the reboot/reset maneuver with him to reset the valve if possible.He is going to try that and if he does not have success, he is going to make an appointment with the surgeon.Patient asked about warranty and patient liaison gave him the warranty process.He stated that in the past, the surgeon told him that if the device didn't work for him that he would only replace the pump.Patient liaison did review with the patient that changing the entire device would be prudent and that it would be returned for analysis.He also stated that the surgeon suggested the two piece if he had trouble with the three piece.Patient liaison let him know that he could discuss with his doctor the possibility of having the three piece device reimplanted.
 
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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
10700 bren road w
minnetonka MN 55343
MDR Report Key9145504
MDR Text Key166400989
Report Number2183959-2019-66450
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003665
UDI-Public00878953003665
Combination Product (y/n)N
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/27/2020
Device Model Number72404258
Device Catalogue Number72404258
Device Lot Number1000080156
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/12/2019
Initial Date FDA Received10/02/2019
Supplement Dates Manufacturer Received12/09/2020
Supplement Dates FDA Received12/16/2020
Patient Sequence Number1
Patient Age58 YR
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