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

Model Number	40209-014
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Fungal Infection (2419); Wrinkling (2613)
Date of Event	08/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient complained of skin expansion and stretching six months after device implantation.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 skin wrinkling in erect and flaccid state.The patient also acknowledged the statement within the consent form, "i understand that recovery is highly individual and may vary significantly for any particular case.I understand that full rehabilitation can take considerable time, including months, if not years." the device was implanted on (b)(6) 2022.The patient tolerated the procedure well, and there were no complications.The patient rated his pain as 0/10 after the operation.About 8 weeks after implantation, the patient informed the clinic of inflammation and discomfort.After review of the images, it was determined that the patient was experiencing a severe yeast infection; the patient was treated at his local urgent care.On (b)(6) 2023, the patient returned to the office to complain of bilateral protrusions and stretched sutures.After consultation, it was identified that the penile skin had expanded, the lateral sutures had stretched, the implant had angled, scar tissue has formed in the penis, and the patient needed an upgraded implant.It was noted that this issue had developed after the severe yeast infection.The patient underwent the consent process again, signing off on various risks and complications one-by-one.This also included a new consent for revision operations, which states previous surgery on the penis can prolong healing, and that various risks are higher than during the original operation.The original device was removed and replaced with a better fitting implant on (b)(6) 2023.The patient tolerated the procedure well, and there were no complications.The patient rated his pain as 0/10 after the operation.
Event or Problem Description
Patient had initial device removed and upgraded to a new device due to skin expansion and stretching.

• Brand Name: PRE-FORMED PENILE SILICONE BLOCK
• Common Device Name: PENUMA
• 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: 17650213
• Report Number: 3010606546-2023-00057
• Device Sequence Number: 20411641
• Product Code: MIB
• UDI-Device Identifier: B097IMD009LLO1
• UDI-Public: B097IMD009LLO1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 08/30/2023

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 Model Number: 40209-014
• Device Lot Number: 899815
• 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: 08/04/2023
• Initial Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2022
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 99 KG