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

Model Number	IMD009-XL
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930); Pain (1994); Deformity/ Disfigurement (2360)
Date of Event	05/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Event was discovered via email.The patient states he received a penuma implant and that after the operation he experienced extreme pain.He alleges that the implant broke through the skin, making him unable to walk without severe pain and to drip white blood plasma from his penis.
Additional Manufacturer Narrative
Swelling and pain are known side effects of surgical procedures and are not considered serious injury.Risk of migration, erosion and pain are risks associated with every surgical procedure involving placement of a synthetic implant material for cosmetic purposes.Before undergoing the procedure, patients undergo a screening process followed by pre-operative counseling, and all 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 include: "infection or erosion of silicone block requiring removal." "extended penile or scrotal pain and discomfort"."temporary reactions, swelling and/or erythema" may occur."cutaneous hypersensitivity reaction, moderate foreign body reaction".After the implantation, the patient used an unauthorized gel with known side effects which include skin irritation, which can lead to skin thinning and implant erosion.When the patient returned for the explantation, it was noted that the erosion occured in the same area as the unauthorized gel was used.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, lists pain, infection, contracture, and curvature as anticipated adverse events.Implant extrusion/perforation and immigration is listed as an anticipated device deficiency.

• 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: jonathan elist ; 8500 wilshire blvd; suite 707; beverly hills, CA 90211 ; 3106522600
• MDR Report Key: 17098969
• Report Number: 3010606546-2023-00010
• Device Sequence Number: 12715920
• Product Code: MIB
• UDI-Device Identifier: B097IMD009XL1
• UDI-Public: B097IMD009XL1
• Combination Product (Y/N): N
• PMA/510(K) Number: K181387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2023

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: IMD009-XL
• Device Lot Number: 900804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2023
• Initial Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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: Other
• Patient Age: 45 YR
• Patient Sex: Male