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

Model Number 72404251

Device Problems Collapse (1099); Defective Device (2588)

Patient Problem Pain (1994)

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

Model number/catalog number: 720185-01, serial number null batch/lot number: (b)(4), model/catalog description: reservoir flat iz 100 ml.

Event Description

It was reported that the patient stated experiencing pain for the past three years with an inflatable penile prosthesis (ipp).The patient also indicated that when trying to activate the device the pump "went flat" and would not refill even after pushing the deflate button.The patient also expressed dissatisfaction with the ipp as it has "at least 25 defects in design".The patient scheduled an assessment appointment with the physician and said would contact patient liaison after the appointment.The patient also stated the possibility of hiring an attorney if the ipp was found to be defective to try and get compensation.Product performance analyst (ppa) was unable to request further information, as customer contact for the account is unknown.No more information available at the moment.Should additional information become available, it will be provided.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE 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 w; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4083953452
• MDR Report Key: 8843294
• MDR Text Key: 152767766
• Report Number: 2183959-2019-65396
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003597
• UDI-Public: 00878953003597
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/20/2018
• Device Model Number: 72404251
• Device Catalogue Number: 72404251
• Device Lot Number: 0150055004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR