MAUDE Adverse Event Report: INTERNATIONAL MEDICAL DEVICES HIMPLANT BY 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 Code	Swelling/ Edema (4577)
Date of Event	08/02/2018
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 included swelling.On (b)(6) 2018 the patient complained of mild swelling.The patient disclosed that this swelling took place after jogging.He was reminded to refrain from engaging in strenuous activities for a few days, to ice, and to follow up the following week.In his follow-up meeting, one week later, it was noted that the patient was healing very well.As a part of the informed consent process, patients are made aware of post-operative instructions.The patient acknowledged and agreed to the following statement: "i understand that some patients have to be in a convalescent status with a generous amount of bed rest for the first week after surgery and that for one month after surgery i will not engage in any stressful physical activity including excessive bending, lifting, or participation in any sports." he also acknowledged that recovery is highly individual and may vary significantly in any particular case.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 was "reminded" to refrain from engaging in strenuous activities, it appears that this patient was not cleared for strenuous activities such as jogging, and thus was reminded to refrain.This is a violation of post-operative instructions.
Event or Problem Description
Patient complained of moderate, post-operative swelling.

• Brand Name: HIMPLANT BY 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: jonathan elist ; 8500 wilshire blvd; suite 707; beverly hills, CA 90211 ; 3106522600
• MDR Report Key: 17506182
• Report Number: 3010606546-2023-00021
• Device Sequence Number: 6101872
• 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: 2018
• 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): 08/10/2023

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: 07/21/2021
• Device Model Number: 40209-004
• Device Lot Number: 867148
• 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: 08/03/2018
• Initial Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2016
• 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: 38 YR
• Patient Sex: Male