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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 Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/22/2019
Event Type  Injury  
Manufacturer Narrative
Device not returned for evaluation.
 
Event Description
It was reported that due to a dimpled pump the patient had his inflatable penile prosthesis (ipp) removed and replaced.It was further reported that when the patient pressed the pump, the pump stayed flat.This occurred three weeks ahead of surgery.The patient got well after this surgery.
 
Event Description
It was reported that due to a dimpled pump the patient had his inflatable penile prosthesis (ipp) removed and replaced.It was further reported that when the patient pressed the pump, the pump stayed flat.This occurred three weeks ahead of surgery.The patient got well after this surgery.
 
Manufacturer Narrative
A pump malfunction was reported.The ams700 momentary squeeze pump was visually inspected and functionally tested.No leak was found.The pump failed the inflation test and did not transfer a sufficient amount of fluid to fully inflate the cylinders.The pump failed the 8 lb.Activation test.The pump required more than 8 lbs.Of force to activate.The product analysis confirmed the alleged pump malfunction.Correction: updated to include device analysis.
 
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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 Key9272343
MDR Text Key164849273
Report Number2183959-2019-67243
Device Sequence Number1
Product Code FHW
UDI-Device Identifier00878953003986
UDI-Public00878953003986
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 12/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/03/2021
Device Model Number72404310
Device Catalogue Number72404310
Device Lot Number0146389003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2019
Date Manufacturer Received12/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age78 YR
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