MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Conceal; prosthesis, penis, inflatable

Model Number	720185-01
Medical Device Problem Codes	Use of Device Problem (1670); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced abdominal pain and herniation of the reservoir.The physician indicated that the patient may not have followed postoperative restrictions and may have lifted a heavy object, which was believed to have contributed to the reservoir herniation.A surgical procedure was performed during which the reservoir was explanted and replaced.No further patient complications were reported.
Additional Manufacturer Narrative
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.Based on the information available, the conclusion code of known inherent risk of device was assigned to this investigation.This record was identified during a retrospective review of complaint events; an electronic medical device report (emdr) was not previously submitted per applicable reporting criteria.Boston scientific has opened a nonconforming events and prevention investigation ((b)(4)) to determine the potential cause for why an emdr was not previously submitted to the food and drug administration (fda) in accordance with boston scientific's established medical device reporting process and fda adverse event reporting requirements.Information gained through these investigation efforts will be utilized to take action(s), as necessary.

• 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: 50883231
• Report Number: 2124215-2026-50879
• Device Sequence Number: 9827073
• Product Code: JCW
• UDI-Device Identifier: 00878953005669
• UDI-Public: (01)00878953005669(17)270513(10)1100728126
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 1100728126
• 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: 04/21/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 05/13/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Unknown