MAUDE Adverse Event Report: GIDDY HOLDINGS, INC. GIDDY; DEVICE, EXTERNAL PENILE RIGIDITY

Device Problems Structural Problem (2506); Patient-Device Incompatibility (2682)

Patient Problem Hematoma (1884)

Event Description

I have erectile dysfunction.The product is a ring that fits at the base of the penis.The selling feature of the product is the unique shape for better erections.On (b)(6) i tried one and did not have much success with it, it felt big.On (b)(6) i developed hematomas all over my penis.I called the company and said i had an "adverse event" and had no process to deal with it.I called my physician who advised that the product is unsafe and i came close to permanent injury.They have no controls in place for reporting adverse events and i was injured.I don't see any of these but i used a size b.Put a search in for eddie by giddy and you can find product on web.It is also sold on (b)(6).

• Brand Name: GIDDY
• Type of Device: DEVICE, EXTERNAL PENILE RIGIDITY
• Manufacturer (Section D): GIDDY HOLDINGS, INC.
• MDR Report Key: 16444478
• MDR Text Key: 310305485
• Report Number: MW5115210
• 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: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2023
• Patient Sequence Number: 1