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

Model Number	40209-004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Swelling/ Edema (4577)
Date of Event	12/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient complained of moderate swelling.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 swelling.Swelling is a common and anticipated event following any surgical procedure.On (b)(6) 2018, the patient complained of mild swelling.The patient was examined virtually and it was noted that the swelling was minor and "likely due to excessive sitting while working." the patient was further instructed to sit in an inclined position, to place pillow on lower back, or to use a standing desk.He was also recommended to avoid squatting or bending and to ice and elevate the penis.It was also noted that this was the patient's first follow-up after the procedure despite post-operative instructions.As a part of the informed consent process, patients are made aware of post-operative instructions.The patient acknowledged and agreed to the following statements: "i will follow all given post-operative instructions; i will appear on days 1,2,3 and 4 immediately after surgery for scheduled follow-ups; i will appear at least once weekly for follow-up appointments (in person or via email) for at least 8 weeks after surgery.The patient did not follow post-operative instructions and did not follow-up until nearly 6 months after the procedure.
Event or Problem Description
Patient complained of moderate swelling and inflammation.

• 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: 17541767
• Report Number: 3010606546-2023-00024
• Device Sequence Number: 20683376
• Product Code: MIB
• UDI-Device Identifier: B097IMD006L1
• UDI-Public: B097IMD006L1
• 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: 2018
• 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: 10/17/2021
• Device Model Number: 40209-004
• Device Lot Number: 868568
• 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: 12/31/2018
• Initial Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2016
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 68 KG