MAUDE Adverse Event Report: HERCULES NIGHT RIDER; DEVICE, EXTERNAL PENILE RIGIDITY

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problems Bruise/Contusion (1754); Discomfort (2330)

Event Date 08/13/2022

Event Type  Injury  

Event Description

Use of an otc device called "hercules night rider" purchased at a local starship.Device is sold as a "novelty" and contains only use warnings not to use on swollen or lacerated areas.Subject experienced grade 3 penile bruising in three areas on the penile shaft just trying to place the device.Penile shaft is severely bruised and sore.Seller of the device has been notified of the injury on (b)(6) 2022.Response is pending.No laboratory tests required.Starship is the company.Fda safety report id# (b)(4).

• Brand Name: HERCULES NIGHT RIDER
• Type of Device: DEVICE, EXTERNAL PENILE RIGIDITY
• MDR Report Key: 15242887
• MDR Text Key: 298232013
• Report Number: MW5111541
• Device Sequence Number: 1
• Product Code: LKY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/15/2022

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2022
• Patient Sequence Number: 1
• Treatment: AMITRYPTILINE ; MULTIVITAMIN; TESTERONE
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 82 KG
• Patient Race: American Indian Or Alaskan Native