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

Model Number	40209-005
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	02/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient complained of infection.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 infection of the silicone block requiring removal.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, implant infection is listed as an anticipated adverse event.The instructions for use (ifu) also identifies infection as an adverse reaction or complication that can occur from skin contamination.After further communication with the physician's office who performed the implantation, it was determined that the infection, then subsequent removal of the implant was due to the patient not following post-op instructions.They also confirmed that the infection was superficial and was not drug resistant.
Event or Problem Description
Patient complained of infection, and the implant was removed.

• 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: 17501942
• Report Number: 3010606546-2023-00036
• Device Sequence Number: 14036508
• Product Code: MIB
• UDI-Device Identifier: B097IMD006XL1
• UDI-Public: B097IMD006XL1
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K181387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 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 Model Number: 40209-005
• Device Lot Number: 896434
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• 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: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 104 KG