FDA Adverse Event
Summary report: N
GIDDY
MDR report key: 16444478
·
Received February 27, 2023
Report
- Report Number
- MW5115210
- Date Received
- February 27, 2023
- Report Date
- February 27, 2023
- Manufacturer
- GIDDY HOLDINGS, INC.
- Product Code
- LKY
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
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).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 398997 | GIDDY | DEVICE, EXTERNAL PENILE RIGIDITY | LKY | GIDDY HOLDINGS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |