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

Model Number	40209-008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient complained of mild pain and moderate swelling/inflammation.
Additional Manufacturer Narrative
The patient complained of moderate pain and swelling.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 extended penile or scrotal pain and discomfort and swelling.The patient complained on (b)(6) 2021 of slight pain and penile swelling.The patient was instructed to ice, elevate, compress, and rest.One week later the patient had no further complaints.It was noted that he was healing well.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, pain is listed as an anticipated adverse event.The instructions for use (ifu) also identify pain as a potential adverse event, which is communicated to the patient prior to implantation.The ifu also states that pain can vary in both intensity and duration following device implantation.The patient was also informed that the time frame of healing can vary from person to person.The date of the reported complaint is less than one-week post-operation.Pain and swelling are common and anticipated side effects of any surgical procedure, especially close to surgical date when healing and recovery is still ongoing.The ifu states that pain can vary in both intensity and duration following device implantation.The patient was also informed that the time frame of healing can vary from person to person.Per email communication with the surgeon every 2 weeks following the procedure, the patient did not complain of further pain or swelling.The patient sent photo updates as discussed in post-operative guidelines, which showed healthy healing progress.

• 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: 17542271
• Report Number: 3010606546-2023-00032
• Device Sequence Number: 20725499
• Product Code: MIB
• UDI-Device Identifier: B097IMD006XLO1
• UDI-Public: B097IMD006XLO1
• 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: 2021
• 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: 12/21/2025
• Device Model Number: 40209-008
• Device Lot Number: 891039
• 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: 03/02/2021
• Initial Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2020
• 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: 61 YR
• Patient Sex: Male