• 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); Deflation Problem (1149); Inflation Problem (1310); Mechanical Problem (1384)
Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Event Date 12/14/2020
Event Type  Injury  
Event Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) procedure due to the pump was sticky and never worked.The pump was removed and replaced.No patient complications were reported in relation to this event.
 
Event Description
It was reported that the patient underwent an inflatable penile prosthesis (ipp) procedure due to the pump was sticky and never worked after a month being implanted.The pump was removed and replaced.No patient complications were reported in relation to this event.
 
Manufacturer Narrative
The complaint component was returned and analyzed, and the reported allegation was confirmed via product analysis.The ams 700 momentary squeeze (ms) pump was visually inspected and functionally tested; no leaks were found.The pump was functionally tested and failed the 8lb.Activation test.The pump therefore required more than 8lbs.Of force to activate.Product analysis concluded these activation issues could affect the functionality of the pump.Based on this investigation, the investigation conclusion code of cause traced to component failure was chosen because the reported events could be traced to a component failure.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.
 
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 Key11098168
MDR Text Key224511601
Report Number2183959-2020-06195
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
Report Date 01/28/2021
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 Manufacturer01/08/2021
Initial Date Manufacturer Received 12/14/2020
Initial Date FDA Received12/30/2020
Supplement Dates Manufacturer Received01/08/2021
Supplement Dates FDA Received01/28/2021
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age73 YR
-
-