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	Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 10/23/2023, the patient reported severe swelling in the penis that began four weeks prior.The patient elected to have the implant removed.
Additional Manufacturer Narrative
Swelling is a known side effect of any cosmetic surgical procedure.Before undergoing the procedure, patients undergo a screening process followed by pre-operative counseling, and all the possible benefits, risks, complications, and alternatives, including no surgery, will be discussed in advance of the surgery.As part of the informed consent process, the patient signed off on various risks and complications one-by-one.The relevant one is: "temporary reactions, swelling and/or erythema" may occur.The post-operative handbook includes information about the swelling of the penile shaft, scrotum, and lower abdomen for approximately one to two weeks after the procedure.On 10/23/2023, when the patient first reported the event, he endorsed participating in mma/kick-boxing event as a competitor, where he was continuously hit in the penile area, and engaging in sexual activity the day before the alleged swelling occurred.The patient then presented to the office on (b)(6) 2023, and despite advice to maintain the implant by the physician, the patient elected to have the implant removed due to his active lifestyle.The patient stated that he did not have any issues with the implant.The root cause is traced to the user, as he participated in activities that directly led to the reported event.The explantation was user preference, and as the patient stated, not due to any issues with the implant.

• 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: 18552655
• Report Number: 3010606546-2024-00003
• Device Sequence Number: 12365148
• 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: 2017
• Device Explanted Year: 2023
• 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): 01/22/2024

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: 07/29/2021
• Device Model Number: 40209-004
• Device Lot Number: 867148
• 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: 01/09/2024
• Initial Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2016
• 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: 43 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White