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

Model Number	40209-004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	12/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient complained of moderate swelling and pain at incision line.
Additional Manufacturer Narrative
The patient complained of moderate pain and moderate swelling at the incision line.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 include extended penile or scrotal pain and discomfort and swelling.One day after the procedure, the patient returned with a drain full (not activated) and dressing was removed 2 hours after surgery.The patient reported that the dressing fell off on its own.The surgeon recorded this as a noncompliance and repeated the instructions to the patient three times.On (b)(6) 2018 the patient was cleared for sexual activity and showed no signs of swelling or inflammation from surgical site or around the penis.On (b)(6) 2018 the patient called to explain concerns regarding mild inflammation and pain.He reported wearing tight jeans to work.He was advised to avoid strenuous exercises, applying pressure to the lower abdomen, and to take tylenol.There were no recorded skin abnormalities, urinary issues, or abrasion/erosion.He was advised to follow up the following week if the pain and swelling persisted.No follow-up was recorded.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, pain is listed as an anticipated adverse event.The instructions for use (ifu) also identify pain as a potential adverse event, which is communicated to the patient prior to implantation.The ifu also states that pain can vary in both intensity and duration following device implantation.The patient was also informed that the time frame of healing can vary from person to person.One day post-operation, the patient had already shown negligence with following post-operative instructions.Tight jeans, as recorded within the progress notes, may have contributed to mild pain and inflammation.The patient's history with lack of following post-operative care in combination with wearing tight clothing near the surgical site are likely causes for the patient's identified concerns.

• 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: chandler thames ; 8500 wilshire blvd; suite 707; beverly hills, CA 90211 ; 3106522600
• MDR Report Key: 17541655
• Report Number: 3010606546-2023-00023
• Device Sequence Number: 12367789
• Product Code: MIB
• UDI-Device Identifier: B097IMD006L1
• UDI-Public: B097IMD006L1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K042380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 08/14/2023

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: 04/19/2021
• Device Model Number: 40209-004
• Device Lot Number: 865669
• 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: 12/14/2018
• Initial Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2016
• 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: 26 YR
• Patient Sex: Male