MAUDE Adverse Event Report: INTERNATIONAL MEDICAL DEVICES, INC. PENUMA IMPLANT; ELASTOMER, SILICONE BLOCK

Model Number	K162624
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	10/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
I am writing to make you aware of dr (b)(6) establishment (b)(6) i would be grateful if you would investigate my findings in full.The full details of my findings are as follows: after having testicular cancer, i thought penile implant and a replacement testicular implant (b)(6) would help with my confidence, but unfortunately it has gone from bad to worse, after getting involved with dr (b)(6) establishment.The issue started when i went ahead and had surgery to get a penile implant ((b)(6) 2018), i knew from day one after having the surgery that i had made a mistake getting penile implant.The short story is that after 8 months of suffering i had the penile implant removed, which has caused serious damage to my penis (i have photos of damage), in which am currently trying to fund and seek treatment for scar retraction and deformity of my penis after penile implant removal.After doing some serious research that penile implants should only be used on pts with erectile dysfunction or penile mutilation / trauma (or in dr (b)(6) words the cosmetic correction of soft tissue deformities: (b)(6) see below for conflicting sites of the uses of dr (b)(6) penile implant: (b)(6) / (advertising of implant) (b)(6) / (manufacturer? does not seem like lawful mfr) fda approved use: (the pre-formed penile silicone block is intended for use in the cosmetic correction of soft tissue deformities and is contoured at the surgeon's discretion to create a custom implant.) https://www.Accessdata.Fda.Gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.Cfm?fr=874.3620 https://www.Accesstata.Fda.Gov/scripts/cdrh/cfdocs/cfpmn/pmn.Cfm?id=k162624 https://www.Accessdata.Fda.Gov/cdrh_docs/pdf18/k181387.Pdf https:/www.Accessdata.Fda.Gov/cdrh_docs/pdf16/k162624.Pdf finally, just to make it clear i had no deformities or function issues of my penis before surgery.Ideally, i would like a refund of cost of penile implant and had surgery to pay for treatment due to the damage of my penis but corresponding with dr (b)(6) establishment, this is not likely to happen.The aftercare and service i have received from dr (b)(6) establishment has been shocking and terrible (i have email corresponding and photos if needed).I hope to receive acknowledgement of this report and am happy to provide my medical reports i requested of dr (b)(6) and my email corresponding and photos with dr (b)(6) establishment.Yours faithfully, (b)(6).Please note, i am an overseas patient ((b)(6)).Fda safety report id# (b)(4).

• Brand Name: PENUMA IMPLANT
• Common Device Name: ELASTOMER, SILICONE BLOCK
• Manufacturer (Section D): INTERNATIONAL MEDICAL DEVICES, INC.
• MDR Report Key: 9166762
• Report Number: MW5090262
• Device Sequence Number: 2861413
• Product Code: MIB
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 10/03/2019

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?: Yes
• Operator of Device: No Information
• Device Model Number: K162624
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 28 YR