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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
Model Number UNK-P-IPP
Device Problems Collapse (1099); Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/14/2020
Event Type  Malfunction  
Event Description

It was reported that patient liaison spoke with the patient on recommendation of local sales representative. The patient is upset because his pump doesn't work and claims that he can't squeeze it to get a pop. He has tried the trouble shooting maneuvers (to include the burp/anti-stiction and reboot) but when he pushes the pump it goes flat and stays flat. Another piece of his frustration is that he can not get anyone from the drs office to return his call. The sales representative met with the patient and he is being scheduled to replace the ipp pump only, unless there is a leak, which they will realize until the pump is exposed in the operating room.

 
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Brand NameAMS INFLATABLE 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
4089353452
MDR Report Key10116674
MDR Text Key193975904
Report Number2183959-2020-02412
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 06/03/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/03/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberUNK-P-IPP
Device Catalogue NumberUNK-P-IPP
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2020
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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