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 Code	Pain (1994)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient complained of moderate pain.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.On (b)(6) 2020, the patient returned for a follow-up after their procedure complaining of pain.The patient identified the pain on a 1-10 scale as a 4.The patient returned for additional follow-ups on (b)(6) 2020 and (b)(6) 2020.He did not report any complaints about pain in either of these follow-ups.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 identifies pain as potential adverse event, which is communicated to the patient prior to implantation.Pain is a common and anticipated side effect of any surgical procedure, especially close to surgical date when healing and recovery is still ongoing.The complaint was reported within 1 week of the surgical procedure.Per post-operative guidelines, the patient had additional follow-ups both in person and via email.Just 1 and 2 days after the initial complaint, there were no further concerns with pain, nor in any follow-up communications thereafter.The patient sent photo updates every two weeks as discussed in post-operative guidelines, which showed healthy healing progress.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 in later weeks.
Event or Problem Description
Patient complained of moderate post-operative pain.

• 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: 17542084
• Report Number: 3010606546-2023-00027
• Device Sequence Number: 12650451
• 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: K042380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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: 05/09/2022
• Device Model Number: 40209-008
• Device Lot Number: 871367
• 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: 02/05/2020
• Initial Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2017
• 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: 30 YR
• Patient Sex: Male