MAUDE Adverse Event Report: UNKNOWN APEX XTENDER; DEVICE, EXTERNAL PENILE RIGIDITY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 05/01/2023

Event Type  Injury  

Event Description

Www.Massivenovelties.Com sell a device marketed at stretching the male genitalia.Using this device damaged my own, resulting in a lack of function.Avr novelties llc.

• Brand Name: APEX XTENDER
• Type of Device: DEVICE, EXTERNAL PENILE RIGIDITY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16919846
• MDR Text Key: 315233783
• Report Number: MW5117499
• Device Sequence Number: 1
• Product Code: LKY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/09/2023

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White