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); Swelling/ Edema (4577)
Date of Event	11/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient complained of 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 swelling.On (b)(6) 2019, the patient was emailed from the surgeon's office to follow-up about progress and healing.There is no record that the patient responded to these emails, despite it being a requirement of post-operative guidelines.On (b)(6) 2019, the patient stated he was doing "ok" and was healing fine.He complained of minor swelling following activity.The patient did not elaborate regarding what activity was performed that caused the swelling.The patient was instructed to refrain from performing "activity" and to follow-up if the swelling persists.As a part of the informed consent process, patients are made aware of post-operative instructions.The patient acknowledged and agreed to the following statements: "i will follow all given post-operative instructions; i will appear on days 1,2,3 and 4 immediately after surgery for scheduled follow-ups; i will appear at least once weekly for follow-up appointments (in person or via email) for at least 8 weeks after surgery.The patient was also provided the post-operative handbook which explains that all forms of sexual activity and any lower body exercises or regular exercise routines are not allowed to be resumed until approved by the surgeon and his staff, which is typically 6-8 weeks after the procedure.There is no record of the patient being cleared for any such activities.The patient is made aware of all post-operative instructions and agreed to follow all instructions prior to the procedure.All patients are informed of the post-operative instructions and informed how consistent and engaged post-operative care is essential.They are also informed that the time frame of healing and recovery can vary from person to person.Since this patient does not have a record of being cleared for any sexual/physical activity in addition to not following-up as instructed, this is a violation of post-operative instructions.
Event or Problem Description
Patient complained of moderate swelling and inflammation.

• 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: 17541837
• Report Number: 3010606546-2023-00025
• Device Sequence Number: 6534965
• 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
• 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: 12/31/2023
• Device Model 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: 11/29/2019
• Initial Report FDA Received Date: 08/14/2023
• 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: Other
• Patient Age: 22 YR
• Patient Sex: Male