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

Model Number UNK-P-IPP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Perforation (2001)

Event Date 04/18/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced perforation of the inflatable penile prosthesis (ipp) through the scrotum that resulted in pus and blood.The patient is diabetic and was advised to seek medical assistance, but no surgical intervention has taken place.No other patient complications were reported.

Manufacturer Narrative

Based on the information available, the product analysis of the inflatable penile prosthesis (ipp) was unable to confirm the reported perforation, hemorrhage, purulent discharge, and blood because the device was not returned to boston scientific.Review of the manufacturing and shipping documentation was unable to be performed as the lot numbers and implant dates were unable to be obtained.Further review did confirm that perforation, hemorrhage, purulent discharge, and blood are known risks with this device.These events are anticipated in nature and severity per the instructions for use and hazard analysis.

Event Description

It was reported that the patient experienced perforation of the inflatable penile prosthesis (ipp) through the scrotum that resulted in pus and blood.The patient is diabetic and was advised to seek medical assistance, but no surgical intervention has taken place.No other patient complications were reported.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 14311882
• MDR Text Key: 290957570
• Report Number: 2124215-2022-15104
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNK-P-IPP
• Device Catalogue Number: UNK-P-IPP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/06/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other