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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 Problems Labelling, Instructions for Use or Training Problem (1318); Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/21/2020
Event Type  Malfunction  
Event Description

It was reported that the patient had an ambicor penile prosthesis (app) implanted in (b)(6) 2020. The patient indicated no instructions were provided by the physician upon discharge. During a post-op appointment the physician told the patient the device "did not look good" and the physician was unable to get the app to function. Patient liaison and a patient champion attempted to assist the patient but were unable to do so. The patient tried to contact the physician but had "no luck". Patient liaison contacted a local sales representative who would meet with the patient for further training.

 
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Brand NameAMS AMBICOR PENILE PROSTHESIS
Type of DeviceDEVICE 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 w
minnetonka MN 55343
Manufacturer Contact
alyson harris
10700 bren road w
minnetonka, MN 55343
4083953452
MDR Report Key10388752
MDR Text Key202358692
Report Number2183959-2020-03419
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
Type of Report Initial
Report Date 08/10/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/10/2020
Is This An Adverse Event Report? No
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
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2020
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?
Type of Device Usage Initial

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