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

Model Number UNK-P-IPP

Device Problem Degraded (1153)

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

Event Date 07/31/2020

Event Type  Injury  

Event Description

It was reported that the patient experienced a surgical procedure to replace an inflatable penile prosthesis (ipp) device due to the inner material of the right cylinder being compromised.A patient outcome was not reported.

Event Description

It was reported that the patient experienced a surgical procedure to replace an inflatable penile prosthesis(ipp) device due to the inner material of the right cylinder being compromised.A patient outcome was not reported.

• 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: 10446567
• MDR Text Key: 204163317
• Report Number: 2183959-2020-03731
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 10/23/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 61 YR