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

Model Number	40209-007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	11/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient complained of moderate swelling and dissatisfaction with aesthetic result.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 patient or partner dissatisfaction with firmness, size (length and/or girth) of erection and swelling.On(b)(6) 2018, the patient complained of swelling.He had not had any previous follow-ups despite post-operative care instructions.He also reported he had not been using tubi-heal for several weeks and was reminded to wear it.He did not follow-up further despite being contacted by the surgeon's office for updates.The instructions for use (ifu), which were reviewed as part of the 510(k) process, identify dissatisfaction with cosmetic results as a potential complication, which is communicated to the patient prior to implantation.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; i understand that i will need to wrap my penis using the tubigrip compression sock during the day and remove it at night for approximately 8 weeks after my procedure or until told otherwise by the surgeon.The tubigrip compression sock is worn to assist with post-operation swelling.The patient did not comply to any of these statements, thus failing to follow post-operative instructions.
Event or Problem Description
Patient complained of moderate swelling and dissatisfaction with cosmetic result.

• Brand Name: HIMPLANT BY 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: 17515405
• Report Number: 3010606546-2023-00022
• Device Sequence Number: 17507823
• Product Code: MIB
• UDI-Device Identifier: B097IMD006LLO1
• UDI-Public: B097IMD006LLO1
• 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): 08/11/2023

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: 04/27/2023
• Device Model Number: 40209-007
• Device Lot Number: 877155
• 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: 11/13/2018
• Initial Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2018
• 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: 30 YR
• Patient Sex: Male
• Patient Weight: 111 KG