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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 72404233
Device Problems Collapse (1099); Fluid/Blood Leak (1250); Inflation Problem (1310); Material Puncture/Hole (1504)
Patient Problem Abdominal Pain (1685)
Event Date 05/17/2020
Event Type  Injury  
Event Description
It was reported that the patient indicated that when he attempted to use the inflatable penile prosthesis on (b)(6) 2020, he experienced a burning pain in his lower abdomen and then he noticed that he could not inflate his device.He stated that the bulb goes flat and stays flat until he pushes the deflate button and he feels that the bulb does not feel normal.
 
Event Description
It was reported that the patient indicated that when he attempted to use the inflatable penile prosthesis on (b)(6) 2020, he experienced a burning pain in his lower abdomen and then he noticed that he could not inflate his device.He stated that the bulb goes flat and stays flat until he pushes the deflate button and he feels that the bulb does not feel normal.The device would not cycle and the pump stayed deflated.The inflatable penile prosthesis was removed and replaced.It was found that the tubing leading to the pump was severed, creating the leak no further complications.
 
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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 Key10151637
MDR Text Key195094837
Report Number2183959-2020-02506
Device Sequence Number1
Product Code FHW
Combination Product (y/n)N
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 08/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/16/2014
Device Model Number72404233
Device Catalogue Number72404233
Device Lot Number780667005
Was Device Available for Evaluation? No
Date Manufacturer Received07/22/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age45 YR
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