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

Model Number	IMD006-XL
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	10/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6)2024 the patient had the device removed due to scar tissue formation.
Additional Manufacturer Narrative
Before undergoing the procedure, patients will have to go through a screening process followed by pre-operative counseling, and that all of the possible benefits, risks, complications, and alternatives, including no surgery, will be discussed in advance of the surgery.As part of the informed consent process, the patient signed off on various risks and complications one-by-one.The relevant ones are - "moderate to severe scar tissue formation" and "seroma".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, scar formation was listed as an anticipated adverse events.The root cause can be traced to user error.The patient stated that his partner aggressively manipulated his penis after sex and a seroma formed.Scar tissue is a common side effect in any implant procedure.

• Brand Name: PRE-FORMED PENILE SILICONE BLOCK
• Common Device Name: HIMPLANT
• 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 90210
• Manufacturer Contact: molly layne ; 8500 wilshire blvd; suite 707; beverly hills, CA 90210 ; 3106522600
• MDR Report Key: 20501204
• Report Number: 3010606546-2024-00006
• Device Sequence Number: 7472005
• Product Code: MIB
• UDI-Device Identifier: B097IMD006XL1
• UDI-Public: B097IMD006XL1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/21/2024

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 Model Number: IMD006-XL
• Device Lot Number: 903376
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 37 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: Asian