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

Model Number	EXTRA LARGE - EXTRA LONG - SOFT
Medical Device Problem Codes	Migration or Expulsion of Device (1395); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Deformity/ Disfigurement (2360); Implant Pain (4561)
Date of Event	05/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Events were discovered when lawsuit "john doe 9 plaintiff vs international medical devices.Et al" was provided to the quality team.The lawsuit claims that this patient had complications as a result of receiving a penuma implant.This patient was implanted with the penuma implant on (b)(6) 2020.The patient had the implant removed on (b)(6) 2022.An additional surgery was completed on (b)(6) 2022 to address the scar tissue, penile retraction, and curvature.The patient states that he suffered and/or still suffers from painful scar tissue, implant flaring, swelling, painful curvature, pain during sex and/or inability to engage in sex.The international medical devices team believes it has likely identified the patient due to the implantation date and correspondence with the clinic; however, counsel for the patient has not yet revealed the patient's identity.
Additional Manufacturer Narrative
Swelling and pain are known side effects of surgical procedures and are not considered serious injury.Before undergoing the procedure, patients will have to go through a screening process followed by pre-operative counseling, and that all of 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: "moderate to severe scar tissue formation", "penile shortening and/or possible penile/implant misalignment", "continued bending, instability and/or wrinkling of the penis and/or implant in erect and flaccid states", "penile deformity", "penile retraction in erect and flaccid states", "extended penile or scrotal pain and discomfort", "any deviation from the post-operative instructions will likely result in additional complications and risks, which may require additional treatment, including potential surgery." 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, penile contracture, and penile curvature as anticipated adverse events.Implant extrusion/perforation are listed an anticipated device deficiency.22 months after successful placement of the implant, the patient desired implant removal, stating loss of length and difficulty with sexual activity.Upon examination, there were no skin deformities, no limitation on movement of his penis nor in penile function were observed.The length and girth of the penis had improved significantly.The patient's erections and penile skin sensation were normal.Nevertheless, the patient desired removal.The patient signed off on various risks and complications one-by-one.The implant removal procedure was successfully completed with no complications.The patient reported low pain levels (0 and 1 out of 10) following the procedure.The patient presented again months after removal for removal of scar tissue.The patient stated he was distressed due to the shape and length of his penis in the erect state, erectile pain, and upwards penile curvature in the erect state.The option of scar tissue removal was discussed, and the patient decided to pursue this option after consenting to the possible risks and complications verbally and in writing.The procedure was successfully completed with no complications.The patient immediately rated his pain a 5/10 after the procedure.The prior implant removal was deemed unnecessary by dr.Elist based on the patient's experience with the device.This unnecessary removal may have led to additional complications such as the formation of scar tissue.
Event or Problem Description
This complaint is being opened related to a lawsuit, case no.(b)(4), however, this is a follow-up to a previously submitted (b)(4).The lawsuit reports that the patient experienced pain and protrusion.
Additional Manufacturer Narrative
As part of the informed consent process, the patient signed off on various risks and complications one-by-one, including: "extended penile or scrotal pain and discomfort." per the clinical investigation report: retrospective analysis of the safety and effectiveness of the silicone block in penile surgery, and the instructions for use, which were reviewed as part of the 510(k) process, lists pain as an anticipated adverse event and implant extrusion/perforation as anticipated device deficiency.Pain is a common and anticipated event in any surgical procedure.The root cause of this investigation is known inherent risk of the device.A review of the batch record was previously performed, and the device was manufactured to specification with no deviations.Udi related data quality updates only: the manufacturing date is not included in the label as pi.The brand name, model #, and udi were corrected.

• Brand Name: SILICONE BLOCK
• 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: 17191109
• Report Number: 3010606546-2023-00014
• Device Sequence Number: 14312147
• Product Code: MIB
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2024

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: 02/21/2025
• Device Model Number: EXTRA LARGE - EXTRA LONG - SOFT
• Device Lot Number: 887068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2020
• 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
• Patient Weight: 96 KG