MAUDE Adverse Event Report: SAALT, LLC SAALT; SAALT CUP

Model Number SAALT CUP

Device Problem Difficult to Remove (1528)

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

Event Date 10/30/2019

Event Type  malfunction  

Event Description

Customer emailed saalt on 10/30/2019 to inform saalt that she went to see a medical provider to have her cup removed.She did not reach out to saalt before the incident to ask for removal techniques and advice.Saalt responded on 10/31/2020 to offer refund and proper removal techniques.No customer response, sent follow-up email 11/27/19.No customer response, sent final follow-up email 12/4/2019.No customer response.

• Brand Name: SAALT
• Type of Device: SAALT CUP
• 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: 9720776
• MDR Text Key: 205323357
• Report Number: 3014276660-2020-20048
• 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: 02/04/2020

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: SAALT CUP
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 02/18/2020
• 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