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	Implant Pain (4561)
Date of Event	02/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient complained of moderate pain and dissatisfaction with aesthetic result.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: patient or partner dissatisfaction with firmness, size (length and/or girth) of erection, and extended penile or scrotal pain and discomfort.On (b)(6) 2017 the patient complained of pain to the suprapubic area.He was seen via facetime.The patient reported the protrusion resolves in the erect state.The physician informed the patient that this indicates the sutures are intact and the implant is well-positioned.The patient reported engaging in rough sexual activity prior to the onset of pain.The physician instructed the patient to refrain from sexual activity for a week.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, in addition to dissatisfaction with cosmetic result, as potential adverse events/complications, which is communicated to the patient prior to implantation.The ifu also advises patients that any sexual activity should be avoided until the physician states that sexual activity is safe.There is no documentation confirming that sexual activity was deemed safe at this point within the patient's medical records.The patient agreed within the signed consent form, "i agree and understand that.Excessive manipulation of my penis can lead to the newly place sutures to become dislodged, resulting in protrusions on the penile shaft." the patient admitted to rough sexual activity, and that pain occurred after this sexual activity.It can be concluded that the pain was caused by rough sexual activity (i.E.User error), since this is against post-operative care that was acknowledged and agreed upon by the patient.
Event or Problem Description
Patient complained of moderate pain and dissatisfaction with aesthetic result.

• 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: 17506007
• Report Number: 3010606546-2023-00019
• Device Sequence Number: 6216868
• 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: 2016
• 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: 04/15/2021
• Device Model Number: 40209-004
• Device Lot Number: 865859
• 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: 02/24/2017
• Initial Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2016
• 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: 56 YR
• Patient Sex: Male