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

Model Number	27-896434-3171
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Seromas are a risk associated with every surgical procedure involving placement of a synthetic implant material for cosmetic purposes.The patient is made aware of potential risks and complications prior to operation including seromas.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 seroma as an anticipated adverse event.The patient reported using hydrogen peroxide on the wound and then using a tanning bed.Hydrogen peroxide is a harsh chemical that is known to be irritating and drying to the skin.The post-operative instructions state, "keep the skin well hydrated as to prevent it from drying out." hydrogen peroxide and tanning beds both have a drying effect on the skin, and together can cause skin complications.This is against post-operative guidelines.It is recommended to wait at least 6 weeks before exposing any fresh incision to a tanning bed.It is not identified when the tanning bed was used.The root cause is that the patient failed to follow-post operative guidelines.It is not clear if the explantation was due to medical intervention or patient requested.
Event or Problem Description
Approximately 6 weeks after implantation, the patient developed seroma.The patient reported using the tanning bed and hydrogen peroxide.The device was explanted on (b)(6) 2022.Imd was made aware of this event by (b)(6) from advanced urology several months after the event occurred.

• 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: 17605152
• Report Number: 3010606546-2023-00055
• Device Sequence Number: 17713056
• 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,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: 27-896434-3171
• Device Catalogue Number: 40209-005
• Device Lot Number: 896434
• 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: 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: 27 YR
• Patient Sex: Male
• Patient Weight: 87 KG