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

Model Number	40209-007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Swelling/ Edema (4577)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient complained of moderate pain and swelling/inflammation.
Additional Manufacturer Narrative
The patient complained of moderate pain and moderate 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.On (b)(6) 2021, the patient complained of some pain and swelling in penile area.The patient denied fever/chills, skin abnormalities.He stated that the pain was usually felt in certain positions.The patient was reminded by the surgeon to sit in an inclined position to avoid adding pressure to the lower body.On (b)(6) 2021, the patient called for a follow-up where he noted that the pain "was much better with intensity, and much more tolerable." for his 6-week follow-up, the surgeon noted that the patient was healing well and had "no discomfort." 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 date of the reported complaint is 5 days 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.After the patient's 6-week follow-up there were no further complaints or information regarding the patient's pain and swelling.The root cause can be attributed to expected post-surgical events in any implanted medical device within the first weeks of recovery.These events were temporary and not prolonged or permanent events as they were not reported after the 6-week follow-up.

• 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: 17549245
• Report Number: 3010606546-2023-00030
• Device Sequence Number: 20546708
• 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: 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): 08/15/2023

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: 07/31/2025
• Device Model Number: 40209-007
• Device Lot Number: 888489
• 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: 01/28/2021
• Initial Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2020
• 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: 29 YR
• Patient Sex: Male
• Patient Weight: 77 KG