MAUDE Adverse Event Report: INTERNATIONAL MEDICAL DEVICES PENUMA; PRE-FORMED PENILE SILICONE BLOCK

Model Number	40209-008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Swelling/ Edema (4577)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient complained of moderate swelling and possible infection.As part of the informed consent process, the patient signed off on various risks and complications one-by-one.The relevant risks signed off by the patient include infection of silicone block or infection of incision and swelling.Surgeon followed-up with patient on day of surgery, on (b)(6) 2021, (b)(6) 2021, and (b)(6) 2021.Patient did not respond despite post-operative instructions.The patient did follow-up on (b)(6) 2021 with photos.On (b)(6) 2021, the patient called to complain of mild-moderate swelling and possible infection.The patient had an in-office exam which showed no indication of infection.Patient has had consistent follow-ups since, with no swelling or potential infection was mentioned in any follow-ups after the initial complaint.Per the clinical investigation report: retrospective analysis of the safety and effectiveness of the silicone block in penile surgery, which was reviewed as part of the 510(k) process, infection is listed as an anticipated adverse event.The instructions for use (ifu) also identify infection as a potential adverse event, which is communicated to the patient prior to implantation.The date of the reported complaint is less than 1 week from date of operation.Swelling is a common and anticipated side effect of any surgical procedure, especially close to surgical date when healing and recovery is still ongoing.The post-operative handbook that was given to the patient states, "you may experience some swelling and/or bruising of the penile shaft, scrotum, and lower abdomen for approximately one to two weeks after the procedure.".
Event or Problem Description
Patient complained of moderate swelling and possible infection.

• Brand Name: PENUMA
• Common Device Name: PRE-FORMED PENILE SILICONE BLOCK
• Manufacturer (Section D): INTERNATIONAL MEDICAL DEVICES; 8500 wilshire blvd; suite 707; beverly hills CA 90211
• Manufacturer (Section G): INTERNATIONAL MEDICAL DEVICES; 8500 wilshire blvd; suite 707; beverly hills CA 90211
• Manufacturer Contact: chandler thames ; 8500 wilshire blvd; suite 707; beverly hills, CA 90211 ; 3106522600
• MDR Report Key: 17542138
• Report Number: 3010606546-2023-00031
• Device Sequence Number: 17734913
• Product Code: MIB
• UDI-Device Identifier: B097IMD006XLO1
• UDI-Public: B097IMD006XLO1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K042380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2023

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: Health Professional
• Device Expiration Date: 12/21/2025
• Device Model Number: 40209-008
• Device Lot Number: 891039
• 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: 02/25/2021
• Initial Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2020
• 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: Other
• Patient Age: 40 YR
• Patient Sex: Male