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

Model Number UNK-P-IPP

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2020

Event Type  Injury  

Event Description

It was reported that the inflatable penile prosthesis (ipp) device is going to be revised due to unspecified reasons.

Event Description

It was reported that the inflatable penile prosthesis (ipp) device is going to be revised due to unspecified reasons.Additional information received states the ipp was revised due to an infection.The pump was explanted and a new pump was implanted.The patient status was reported as "very good" following the surgery.

• 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 Key: 9647680
• MDR Text Key: 177022918
• Report Number: 2183959-2020-00353
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 02/20/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention