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

Model Number	40209-006
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	01/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient complained of swelling and inflammation (moderate).
Additional Manufacturer Narrative
The patient complained of moderate swelling and inflammation.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 included swelling.On (b)(6) 2021 the patient complained of mild swelling.On his 1st post-op follow-up on (b)(6) 2021, the surgeon noted in progress notes, "the implant is positioned well.There are no signs of inflammation or swelling.The edges are nice and soft.The scrotal incision line is healing well with no inflammation or swelling." patient was seen again on (b)(6) 2021, where it was noted again that there was "no inflammation or swelling." the complaint was recorded on the day of the operation.Swelling is a common and anticipated side effect of any surgical procedure, especially when healing and recovery is just beginning.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." per progress reports, the patient did not complain of further swelling after the initial complaint.The root cause can be attributed to expected post-surgical events in any implanted medical device within the first weeks of recovery.These events were temporary and not prolonged or permanent events as they were not reported in later weeks.

• 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: 17549213
• Report Number: 3010606546-2023-00029
• Device Sequence Number: 6694925
• Product Code: MIB
• UDI-Device Identifier: B097IMD006XXL1
• UDI-Public: B097IMD006XXL1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162624
• 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): 08/15/2023

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: 07/24/2025
• Device Model Number: 40209-006
• Device Lot Number: 888861
• 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: 01/19/2021
• Initial Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2020
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 58 KG