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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 Malposition of Device (2616)
Patient Problem Discomfort (2330)
Event Date 08/02/2020
Event Type  Injury  
Event Description
It was reported that the patient experienced a replacement of an inflatable penile prosthesis(ipp) due to discomfort and incorrect placement of the original implant.The original procedure was not successful and the patient experienced discomfort after the surgery because the pump was implanted on the wrong side of his body.A new surgeon then removed the old device, resized, and implanted a new device on the correct side.A patient outcome of fully recovered was reported.
 
Manufacturer Narrative
G5 updated.
 
Event Description
It was reported that the patient experienced a replacement of an inflatable penile prosthesis(ipp) due to discomfort and incorrect placement of the original implant.The original procedure was not successful and the patient experienced discomfort after the surgery because the pump was implanted on the wrong side of his body.A new surgeon then removed the old device, resized, and implanted a new device on the correct side.A patient outcome of fully recovered was reported.
 
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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 Key10446568
MDR Text Key204178726
Report Number2183959-2020-03726
Device Sequence Number1
Product Code FHW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 10/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received10/15/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
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