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

Model Number	40209-005
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	05/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient complained of moderate swelling and possible infection.
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.On (b)(6)2020, the patient complained of moderate penile swelling.He did not have any fever, chills, or skin openings.He noted that he felt "under the weather," and was worried of possible infection.The patient was instruction to follow-up with photos.On (b)(6)2020, the patient was seen in-office for an exam.The exam revealed a small vesicle that was sent for culture.The patient was prescribed bactroban for treatment.Patient had a follow-up visit on (b)(6)2020 where the small vesicle was examined and noted as "healed." the surgeon notes that the penis has good movement in all directions and is healing well.On (b)(6)2020, the patient had their 6 month in-office follow up where the incision line was again examined and noted as "nice and soft." there were no other complaints regarding swelling or infection after the initial complaint in any follow-ups 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.Swelling is a common and anticipated side effect of any surgical procedure.

• 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: 17549185
• Report Number: 3010606546-2023-00028
• Device Sequence Number: 6694500
• Product Code: MIB
• UDI-Device Identifier: B097IMD006XL1
• UDI-Public: B097IMD006XL1
• 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: 2020
• 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): 08/15/2023

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: 05/03/2022
• Device Model Number: 40209-005
• Device Lot Number: 871320
• 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: 05/05/2020
• Initial Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2017
• 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: 37 YR
• Patient Sex: Male
• Patient Weight: 104 KG