MAUDE Adverse Event Report: SAALT, LLC SAALT; SMALL BLUSH

Model Number SMALL BLUSH

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

Patient Problem Unspecified Infection (1930)

Event Date 10/28/2020

Event Type  Injury  

Event Description

Customer emailed saalt to explain that they had gotten an infection (customer did not disclose what type of infection) after using their saalt cup.Saalt responded with additional questions about the customer's experience.Saalt made three attempts to contact the customer within 30 days and did not receive a response.

• Brand Name: SAALT
• Type of Device: SMALL BLUSH
• Manufacturer (Section D): SAALT, LLC; 6148 n. discovery way; ste. 175; boise ID 83713
• Manufacturer Contact: bill briley ; 6148 n. discovery way; ste. 175; boise, ID 83713
• MDR Report Key: 10861300
• MDR Text Key: 216964308
• Report Number: 3014276660-2020-01206
• Device Sequence Number: 1
• Product Code: HHE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/17/2020

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: SMALL BLUSH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention