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 01/21/2020

Event Type  malfunction  

Event Description

Customer emailed saalt on (b)(6) 2020 to explain that she had gone to the er to have her cup removed after attempting to remove it for 2 hours.The customer and her friend both tried to remove her cup before deciding to go to the er.Saalt responded on 1/22/2020 to issue a refund and send a replacement cup.Saalt also provided the customer with removal techniques.

• 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; boise, ID 83713 ; 8013682646
• MDR Report Key: 9720791
• MDR Text Key: 205323382
• Report Number: 3014276660-2020-20060
• 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: 02/11/2020

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
• 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: 01/21/2020
• 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