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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
Device Problem Failure to Cycle (1142)
Patient Problem Pain (1994)
Event Date 06/01/2020
Event Type  malfunction  
Event Description
It was reported that the patient is experiencing difficulties with his inflatable penile prosthesis(ipp) device.The device does not activate post operation, the bulb will not pop, and the pump remains hard.The patient reports that previous doctor appointments have not been successful due to pain and the doctor has been dismissive of his concerns.The patient has an appointment scheduled with the doctor in regards to this issue.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
10700 bren road west
minnetonka MN 55343
Manufacturer Contact
alyson harris
10700 bren road w
minnetonka, MN 55343
4089353452
MDR Report Key10211878
MDR Text Key197333176
Report Number2183959-2020-02733
Device Sequence Number1
Product Code FHW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 06/30/2020
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/10/2020
Initial Date FDA Received06/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age80 YR
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