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	Unspecified Infection (1930); Swelling/ Edema (4577)
Date of Event	01/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient complained of moderate swelling and possible infection.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 infection of silicone block or infection of incision.On (b)(6) 2019, one day after the operation, the patient rated his pain a 4 on a scale of 1 through 10.For the patient's first post-op follow-up, the patient stated he was doing fine.It is noted that the patient's implant is positioned well.On (b)(6) 2019, the patient returned for drain removal and again was noted as healing well.On (b)(6) 2020, the patient's sutures were removed.On (b)(6) 2020, the patient expressed that he was "doing good" and urination was normal.The patient expressed concerns of mild penile swelling and possible infection.The patient did not have a fever or chills.He also did not have any irritation or discomfort/pain.He was instructed to ice, elevate, and apply compression.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, infection is listed as an anticipated adverse event.The instructions for use (ifu) also identify infection as a potential adverse event, which is communicated to the patient prior to implantation.The date of the reported complaint is less than 3 weeks from date of operation.Swelling is a common and anticipated side effect of any surgical procedure, especially close to surgical date when healing and recovery is still ongoing.The post-operative handbook that was given to the patient states, "you may experience some swelling and/or bruising of the penile shaft, scrotum, and lower abdomen for approximately one to two weeks after the procedure." on (b)(6) 2020, the patient submitted follow-up photos via email.There were no concerns with the follow-up photos in regard to swelling or possible infection.There was no further information regarding the possible infection or swelling.On (b)(6) 2020, the patient reported that he was "healing fine." in response to these photos, the patient was cleared for all physical and sexual activity.
Event or Problem Description
Patient complained of moderate swelling and possible infection.

• 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: 17543924
• Report Number: 3010606546-2023-00026
• Device Sequence Number: 12617427
• 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: 2019
• 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): 08/14/2023

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: 05/18/2021
• Device Model Number: 40209-004
• Device Lot Number: 866390
• 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: 01/07/2020
• Initial Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2016
• 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: 45 YR
• Patient Sex: Male