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

Model Number	10969-007
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hematoma (1884); Unspecified Tissue Injury (4559)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had initial device removed and upgraded to a new device due to skin expansion and stretching.
Additional Manufacturer Narrative
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 skin wrinkling in erect and flaccid state.The patient also acknowledged the statement within the consent form, "i understand that recovery is highly individual and may vary significantly for any particular case.I understand that full rehabilitation can take considerable time, including months, if not years." the patient tolerated the procedure on (b)(6) 2023 well, and there were no complications.One day after the operation the patient rated their pain a 4/10, which is an acceptable pain for after a surgical operation.On (b)(6) 2023, the patient presented to the office desiring an implant upgrade due to skin expansion and stretching.The patient completed the consent process again, including the possible risks and complications associated with implant removal and upgrade.The patient elected to move forward with the implant removal and upgrade on (b)(6) 2023.Scar tissue was identified and removed.It was confirmed that lateral sutures had loosened.The original implant was removed.A new device was successfully implanted.The patient tolerated the implant removal and upgrade procedure well, and there were no complications.One day after the operation the patient rated their pain a 4/10, which is an acceptable pain for after a surgical operation.On (b)(6) 2023, the patient returned to the office and requested implant removal due to anxiety.It was noted that the patient had excessive activity: walking excessively, slamming on the brakes while driving, and a strenuous bowel movement in the days following the second operation, which is in noncompliance with the healing process.The patient completed the consent process again, including the possible risks and complications associated with implant removal including shrinkage of the penis, shortening of the penis, and formation of scar tissue.The patient elected to move forward with the implant removal on (b)(6) 2023 despite advice to maintain the implant.A large hematoma was evacuated, and the implant was removed.The patient tolerated the implant removal procedure well, and there were no complications.One day after the operation the patient rated their pain a 3/10, which is an acceptable pain for after a surgical operation.Per the clinical investigation report: retrospective analysis of the safety and effectiveness of the silicone block in penile surgery and the ifu, which were reviewed as part of the 510(k) process, dissatisfaction with cosmetic results, scar tissue, and hematoma are listed as a potential adverse events and complications.The clinical investigation report also lists suture detachment as an anticipated device deficiency.Patients should be informed that dissatisfying cosmetic results such as scar deformity, hypertrophic scarring, asymmetry, displacement, incorrect size, unanticipated contour or projection, transillumination and palpability may occur.Careful preoperative planning and surgical techniques are essential to minimize the occurrence of such results.Cosmetic concerns may also become medical concerns.The root cause of this investigation is known inherent risk of the device.The hematoma was due to noncompliance of excessive activity after surgery.

• Brand Name: PRE-FORMED PENILE SILICONE BLOCK
• Common Device Name: PENUMA
• 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: chandler thames ; 8500 wilshire blvd; suite 707; beverly hills, CA 90211 ; 3106522600
• MDR Report Key: 18291768
• Report Number: 3010606546-2023-00066
• Device Sequence Number: 6696082
• Product Code: MIB
• UDI-Device Identifier: B097IMD006LLO1
• UDI-Public: B097IMD006LLO1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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): 12/08/2023

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: 04/29/2025
• Device Model Number: 10969-007
• Device Lot Number: 887821
• 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: 11/09/2023
• Initial Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• 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: 40 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Race: White