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

Model Number	72018201
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not functioning properly, and the ultrasound showed the reservoir empty.The cause of the issue was unknown.A surgical procedure was performed in which a new reservoir was implanted.There were no patient complications reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not functioning properly, and the ultrasound showed the reservoir empty.It was stated that although the pump initially lacked liquid, it recovered after pressing the small button.A surgical procedure was performed in which a new reservoir was implanted.There were no patient complications reported.

• 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: 22286939
• Report Number: 2124215-2025-39740
• Device Sequence Number: 12899376
• Product Code: JCW
• UDI-Device Identifier: 00878953005676
• UDI-Public: (01)00878953005676(17)240925(10)1000337485
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/25/2024
• Device Model Number: 72018201
• Device Catalogue Number: 72018201
• Device Lot Number: 1000337485
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/22/2025
• Date Device Manufactured: 09/27/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male