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

Model Number	IMD006-LLO
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hematomas are a common adverse event in any procedure with placement of a foreign object in the body.As part of the informed consent process, the patient signed off on various risks and complications one-by-one, including: "hematoma." 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 hematoma as an anticipated adverse event.The instructions for use also list hematoma as a potential adverse event.On (b)(6) 2023, the patient complained of hematoma.Within the patient's progress reports, it is noted that the implant was "well placed and secured," on the same day of the complaint.The patient also noted that the area was tender to touch, and the surgeon performed an in-office evaluation.The patient then elected to have the implant explanted.There are notable events leading to this complaint: the patient had an abundance of surgeries prior to the decision for explantation on (b)(6)2023 including: first initial implantation on (b)(6) 2019; implant upgrade and removal of supra pubic fat on (b)(6) 2022; a revision / upgrade / exploration on (b)(6) 2023; a revision / upgrade / exploration on (b)(6) 2023; and another exploration on (b)(6) 2023.With the amount of upgrades and exploration procedures, the patient is at a higher risk for complications.Additionally, with each removal / upgrade, as stated in the consent form, "removal of implant may result in penile retraction, scar formation, and other potential complications, necessitating additional treatment." these procedures made the patient more susceptible to complications, such as the anticipated adverse event: hematoma.3 procedures were specific to the patient's penis and all occurred within 5 months of each other.After his explantation, the patient stated that he was "doing good" and with each follow-up he continued to express that he was healing well.The patient elected to undergo all listed procedures with acknowledgement that these complications are anticipated with each surgery.This is the first complaint of hematoma after a review of all complaints from 2014 to 2023.
Event or Problem Description
The patient desired removal of the implant.A hematoma was evacuated.The device was explanted on (b)(6) 2023.

• 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: 17617384
• Report Number: 3010606546-2023-00038
• Device Sequence Number: 16806165
• 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: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2023

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: 12/31/2023
• Device Model Number: IMD006-LLO
• Device Catalogue Number: 40209-007
• Device Lot Number: 881282
• 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: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2018
• 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: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Weight: 86 KG