MAUDE Adverse Event Report: NATIONAL MEDICAL DEVICES INC. PENUMA IMPLANT ; PENILE SILICONE BLOCK

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	01/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Dr (b)(6) claims he has a 501(k) clearing a product for a penile implant.When looking up his 510(k) #k042380.It states it's for ears nose and throat.He is using this approval to secure trust in pts.It's absolutely meaningless and extremely misleading.This product that mr (b)(6) is using is destroying the lives of many men.He is playing on them, lying on them and leaving them with a mess to deal with afterwards.My husband is pretty disfigured from his procedure, and it is interfering with daily life functions; dr (b)(4).

• Brand Name: PENUMA IMPLANT
• Common Device Name: PENILE SILICONE BLOCK
• Manufacturer (Section D): NATIONAL MEDICAL DEVICES INC.
• MDR Report Key: 7313083
• Report Number: MW5075640
• Device Sequence Number: 15360420
• Product Code: MIB
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: No Information
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Weight: 113