MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONCEAL; PROSTHESIS, PENIS, INFLATABLE

Model Number	720185-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) experienced an infection near the area of the reservoir.A surgical procedure was performed, to remove and replace the ipp.No further patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404232-10.Serial number: n/a.Batch/lot number: 1100874988.Model/catalog description: cx preconnect ms 18cm ps 10cm tl iz.Unique identifier (udi) #: (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.Infection is acknowledged within the instructions for use (ifu) and is not related to off-label use or failure to follow instructions.A risk review was completed, and infection related symptoms are defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.The reported patient symptom of infection is a known risk associated with this device type and indicated as such in the instructions for use.Based on the information available, the conclusion code of known inherent risk of device was assigned to this investigation.

• Brand Name: CONCEAL
• Common Device Name: PROSTHESIS, PENIS, INFLATABLE
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 25166411
• Report Number: 2124215-2026-26015
• Device Sequence Number: 10191191
• Product Code: JCW
• UDI-Device Identifier: 00878953005669
• UDI-Public: (01)00878953005669(17)271208(10)1100844894
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: 720185-01
• Device Catalogue Number: 720185-01
• Device Lot Number: 1100844894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/13/2026
• Date Device Manufactured: 12/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Unknown