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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 72404310
Device Problem Collapse (1099)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/22/2020
Event Type  Injury  
Event Description

It was reported that the patient had the inflatable penile prosthesis pump component removed due to dimpled pump that maintained flat when pressed. The product did not work, so the patient visited the hospital 2 weeks before surgery. A new inflatable penile prosthesis pump was implanted, the patient was stable following the procedure and the event resolved.

 
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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 Key10116124
MDR Text Key193720707
Report Number2183959-2020-02411
Device Sequence Number1
Product Code FHW
Combination Product (Y/N)N
Reporter Country CodeKS
PMA/PMN NumberN970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/06/2021
Device MODEL Number72404310
Device Catalogue Number72404310
Device LOT Number120129005
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/22/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/25/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/03/2020 Patient Sequence Number: 1
Treatment
MODEL # 720182-01LOT # 124844011; MODEL # 72404273LOT # 844685005
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