MAUDE Adverse Event Report: INTERNATIONAL MEDICAL DEVICES PREFORMED PENILE SILICONE BLOCK; PENUMA

Model Number	27-897889-7235
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Erosion (1750); Skin Erosion (2075); Swelling/ Edema (4577)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent revision for flaring of his penuma as well as ventral phalloplasty on (b)(6) 2022 as he had a very prominent penoscrotal webbing ((b)(6) 2022).There was significant skin breakdown from his mid-penile incision since the surgery, due to impromper urowrap use, and he was experiencing increased draining and swelling.The patient also had a mid-scrotal separation and a deep hole with some clots, with no signs of infection.There was ventral curling of his penis from scarring after the surgery.The patient also reported that there was exposure of the distal tip of the implant concerning for erosion.The device was explanted on (b)(6) 2023.Imd was made aware of this event by kristina kloss from advanced urology several months after the event occurred.
Additional Manufacturer Narrative
As part of the informed consent process, the patient signed off on various risks and complications one-by-one, including: "erosion of silicone block," "swelling," and "any deviation from the post-operative instructions will likely result in additional complications and risks, which may require additional treatment, including potential surgery." the post-operative instructions detail that improper use of the urowrap can also cause swelling.The patient failed to follow post-operative guidelines, specifically wearing his urowrap correctly, which, as disclosed to the patient, can result in potential surgery.Per the clinical investigation report: retrospective analysis of the safety and effectiveness of the silicone block in penile surgery, which was reviewed as part of the 510(k) process, lists penile skin ulcer as an anticipated adverse event and implant extrusion/perforation as an anticipated device deficiency.The instructions for use state that skin sloughing may occur due to tension of the skin overlaying the implant, and list extrusion as an anticipated adverse event.The patient's failure to follow post-operative instructions, wearing his urowrap properly, is the root-cause for the events described.

• Brand Name: PREFORMED 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: 17604417
• Report Number: 3010606546-2023-00051
• Device Sequence Number: 17713173
• Product Code: MIB
• UDI-Device Identifier: B097IMD006XLO1
• UDI-Public: B097IMD006XLO1
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2023

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: 27-897889-7235
• Device Catalogue Number: 40209-008
• Device Lot Number: 897889
• 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: 07/26/2023
• Initial Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2022
• 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: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 123 KG
• Patient Ethnicity: Non Hispanic