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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 Problems Break; Loose or Intermittent Connection
Event Date 11/22/2018
Event Type  Injury  
Manufacturer Narrative

Reservoir 65ml pc: (b)(4).

 
Event Description

It was reported that the pump and reservoir replacement due to pump connector breakage and new reservoir connection(old one is still in the patient's body). No injury to the patient was reported due to this event.

 
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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
mike bocchino
10700 bren road w
minnetonka , MN 55343
6515827161
MDR Report Key8157674
Report Number2183959-2018-61599
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,USER FACI
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/30/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/12/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number72404310
Device Catalogue Number72404310
Device LOT Number0129022005
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/17/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/22/2016
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: 12/12/2018 Patient Sequence Number: 1
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