Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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; 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; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number UNK-P-IPP
Device Problems Collapse (1099); Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/14/2020
Event Type  Injury  
Event Description
It was reported that the patient had the inflatable penile prosthesis removed as it was not working correctly.A new lgx inflatable penile prosthesis system was implanted.
 
Manufacturer Narrative
Corrected data e1.
 
Event Description
It was reported that the patient had the inflatable penile prosthesis removed as it was not working correctly.The pump was collapsed and it was not inflating.A new lgx inflatable penile prosthesis system was implanted.
 
Event Description
It was reported that the patient had the inflatable penile prosthesis removed as it was not working correctly.The pump was collapsed and it was not inflating.A new lgx inflatable penile prosthesis system was implanted.
 
Manufacturer Narrative
H3 device evaluation: the ams 700 momentary squeeze (ms) pump was visually inspected; no leaks were found.The pump was functionally tested and failed activation test.Product analysis confirmed the reported events.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AMS INFLATABLE PENILE PROSTHESIS
Type of Device
DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key9915949
MDR Text Key186178571
Report Number2183959-2020-01813
Device Sequence Number1
Product Code FHW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 06/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
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? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2020
Initial Date Manufacturer Received 01/14/2020
Initial Date FDA Received04/02/2020
Supplement Dates Manufacturer Received06/01/2020
06/11/2020
Supplement Dates FDA Received06/02/2020
06/21/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age70 YR
-
-