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

Model Number SMALL PINK

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

Patient Problem Urinary Tract Infection (2120)

Event Date 11/07/2019

Event Type  malfunction  

Event Description

The customer contacted saalt on (b)(6) 2020 to inform saalt that she developed a urinary tract infection.She explained that she felt the discomfort that urinary tract infections can cause, so she decided to seek medical attention.Saalt sent the customer a replacement cup of a softer firmness so the new cup wouldn't put pressure on the customer's urethra.

• Brand Name: SAALT
• Type of Device: SMALL PINK
• Manufacturer (Section D): SAALT, LLC; 6149 n meeker place; boise ID 83713
• Manufacturer Contact: danielle burden ; 6149 n meeker place; garden city, ID 83713 ; 8013682646
• MDR Report Key: 9720763
• MDR Text Key: 190990022
• Report Number: 3014276660-2020-20046
• 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: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SMALL PINK
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: No
• 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