• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72404233-12
Device Problems Collapse; Inadequacy of Device Shape and/or Size; Malposition of device ; Migration
Event Date 06/25/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Reservoir flat iz 100 ml.

 
Event Description

It was reported that patient liaison spoke with a with patient who had an inflatable penile prosthesis (ipp) implanted (b)(6) 2019. He has had complaint since the device was implanted and has worked with both the doctor and a rep whom he said introduced himself as (b)(6). He states that he does not believe that his complaints are all device related but may be operator error; he does not believe the surgeon knew what he was doing. His complaints are: the tubing is wrapped around the shaft of his penis and he states it is very frankenstein looking and painful; he states that his penis is not big enough for intercourse; he says the doctor claimed that the device was sticky, he thinks that is in reference to the pump but was not sure; when he inflates the device he states that his pain is 9/10; he claims that the device does not go far enough out and does not reach his glans; the pump is not accessible where it was placed, he states that it is too close to his anus. The doctor referred him to a doctor at (b)(6) hospital- who after assessment determined that the patient needs a revision surgery. That surgery is scheduled for (b)(6) 2019. The device will be returned for analysis. Patient liaison explained the warranty procedure.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
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 west
minnetonka MN 55343
Manufacturer Contact
alyson harris
10700 bren road w
minnetonka , MN 55343
4089353452
MDR Report Key9154440
Report Number2183959-2019-66585
Device Sequence Number1
Product CodeFHW
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/04/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number72404233-12
Device Catalogue Number72404233-12
Device LOT Number1000274960
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/06/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/14/2019
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: 10/04/2019 Patient Sequence Number: 1
-
-