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

Model Number SMALL GREY

Device Problem Difficult to Remove (1528)

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

Event Date 01/13/2020

Event Type  malfunction  

Event Description

Customer contacted saalt on (b)(6) 2020 to notify saalt that she went to the doctor to have her cup removed.She attempted to remove her cup after 6 hours of wear, and then chose to seek medical care after having the cup inserted for 36 hours.Saalt responded and provided removal techniques and a replacement cup.

• Brand Name: SAALT
• Type of Device: SMALL GREY
• 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: 9720789
• MDR Text Key: 183566183
• Report Number: 3014276660-2020-20057
• 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: 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
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SMALL GREY
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2020
• Was Device Evaluated by Manufacturer?: 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