MAUDE Adverse Event Report: INTERNATIONAL MEDICAL DEVICES PREFORMED PENILE SILICONE BLOCK; PENUMA

Model Number	27-897884-4809
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 2 weeks after implantation, the patient had a midline protrusion of the implant.The device was explanted on (b)(6) 2023.Imd was made aware of this event by (b)(6) from (b)(6) several months after the event occurred.
Additional Manufacturer Narrative
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 implant extrusion/perforation as anticipated device deficiency.The instructions for use also list implant extrusion as a potential adverse event.The reported events occurred 2 weeks post-operation.The explantation was performed over a year after the initial operation and the reported complaint.The batch record was reviewed, and it was manufactured to specification with no deviation.It was not reported if the explantation was medical intervention or patient elected.This is the first report of protrusion after an analysis of all complaints from 2014-2023.

• Brand Name: PREFORMED 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: 17607041
• Report Number: 3010606546-2023-00056
• Device Sequence Number: 6263289
• Product Code: MIB
• UDI-Device Identifier: B097IMD009XXL1
• UDI-Public: B097IMD009XXL1
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2023

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: 27-897884-4809
• Device Catalogue Number: 40209-006
• Device Lot Number: 897884
• 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: 07/26/2023
• Initial Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 113 KG