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

Model Number SMALL PINK

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2019

Event Type  malfunction  

Event Description

Customer attempted to use her cup for the first time, and the following morning of (b)(6) 2019 struggled to remove her cup.She referred to our instructions for removal tips and still could not remove her cup.Her cup had been inserted for 12 hours prior to her removal attempts.She began to panic and went to the minor injuries unit.A nurse was able to successfully remove the cup.Customer was given a refund for her purchase.

• Brand Name: SAALT
• Type of Device: SMALL PINK
• Manufacturer (Section D): SAALT, LLC; 6149 n meeker pl; suite 110; boise ID 83713
• Manufacturer Contact: danielle burden ; 6149 n meeker pl; suite 110; boise, ID 83713 ; 8013682646
• MDR Report Key: 9644666
• MDR Text Key: 188993429
• Report Number: 3014276660-2020-00005
• Device Sequence Number: 1
• Product Code: HHE
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SMALL PINK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2020
• 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