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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 Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 11/21/2023
Event Type  Injury  
Event Description
It was reported that during the removal of another manufacture device, the physician knicked the urethra.The physician fixed the urethra and proceeded to implant this ambicor penile prosthesis.A couple of weeks later he came back in with pain.The device was removed and not replaced.
 
Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
 
Event Description
It was reported that during the removal of another manufacture device, the physician knicked the urethra.The physician fixed the urethra and proceeded to implant this ambicor penile prosthesis.A couple of weeks later he came back in with pain.The device was removed and not replaced.
 
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Brand Name
AMS AMBICOR PENILE PROSTHESIS
Type of Device
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
farshad fahimi
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key18503533
MDR Text Key332785217
Report Number2124215-2024-01466
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 Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberUNK-P-APP
Device Catalogue NumberUNK-P-APP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/30/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age71 YR
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