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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS AMBICOR PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS AMBICOR PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number UNK-P-APP
Device Problem Inflation Problem (1310)
Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Event Date 12/18/2020
Event Type  Injury  
Event Description
It was reported that the patient underwent an ambicor penile prosthesis (app) revision surgery due to the device was not inflating enough.The device was removed and replaced with a new app.No patient complications were reported in relation to this event.
 
Manufacturer Narrative
This report is a duplicate event and is reported under 2183959-2020-03181.Analysis will be submitted after completion under 2183959-2020-03181.
 
Event Description
It was reported that the patient underwent an ambicor penile prosthesis (app) revision surgery due to the device was not inflating enough.The device was removed and replaced with a new app.No patient complications were reported in relation to this event.
 
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Brand Name
AMS AMBICOR PENILE PROSTHESIS
Type of Device
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key11201211
MDR Text Key227744520
Report Number2183959-2020-06397
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,o
Type of Report Initial,Followup
Report Date 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberUNK-P-APP
Device Catalogue NumberUNK-P-APP
Was Device Available for Evaluation? No
Date Manufacturer Received01/27/2021
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age43 YR
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