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

Model Number UNK-P-IPP

Device Problems Collapse (1099); Mechanical Problem (1384); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2019

Event Type  malfunction  

Event Description

It was reported that after going through a sex change procedure the patient had an inflatable penile prosthesis (ipp) implant procedure.Almost two years after this surgery, the patient experienced mechanical issues with the device due to the pump being "hooked".It was also reported that "no tension noises" were heard.Product performance analyst (ppa) was unable to request further information, as customer contact for the account is unknown.

• 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
• 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: 8954009
• MDR Text Key: 156263758
• Report Number: 2183959-2019-65949
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 09/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK-P-IPP
• Device Catalogue Number: UNK-P-IPP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 09/02/2019
• 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