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 72404292
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/08/2020
Event Type  Injury  
Event Description
It was reported that a proximal insertion was attempted several times, but insertion attempts failed as the inflatable penile prosthesis (ipp) (lgx15cm) cylinders were ultimately not inserted.The physician was able to complete this surgery with a cx16cm cylinder.The patient currently has a complete device implanted.The patient is stable and got better following this surgery.
 
Event Description
It was reported that a proximal insertion was attempted several times, but insertion attempts failed as the inflatable penile prosthesis (ipp) (lgx15cm) cylinders were ultimately not inserted.The physician was able to complete this surgery with a cx16cm cylinder.The patient currently has a complete device implanted.The patient is stable and got better following this surgery.
 
Manufacturer Narrative
Both cylinders were returned for analysis.The cylinders were visually inspected and functionally tested; no leaks were found.The cylinders performed within specification.Product analysis was unable to confirm the reported events.Based on the investigation results, an evaluation conclusion code of no problem detected was assigned to this event.
 
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 Key10631896
MDR Text Key209954778
Report Number2183959-2020-04436
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003948
UDI-Public00878953003948
Combination Product (y/n)N
PMA/PMN Number
N970012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 10/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number72404292
Device Catalogue Number72404292
Device Lot Number1000384884
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/06/2020
Date Manufacturer Received10/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
-
-