MAUDE Adverse Event Report: SAALT, LLC SAALT; REGULAR BLUE

Model Number REGULAR BLUE

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 12/18/2020

Event Type  Injury  

Event Description

Customer emailed saalt after choosing to go to emergency room after experiencing bladder pain after cup removal.Saalt responded asking for additional information including: customer's removal techniques, what "bladder symptoms" they experienced, cup mold identifying number, and lot number on the packaging.Customer responded on (b)(6) 2021 with a detailed account of their experience.Customer said she purchased the saalt cup on (b)(6) 2020 and used it for the first time that day.She struggled with removal that day, and felt a bit of discomfort around her urethra.She reinserted and continued wearing the cup.She began to feel bladder discomfort throughout the next few days, and consulted with her doctor on (b)(6) 2020.Her doctor prescribed antibiotics for what they thought may have been a urinary tract infection.She continued taking the antibiotics until (b)(6) 2020 with no relief in symptoms.On (b)(6) 2020, she visited the er with intense bladder pain.The er gave her a urine test, and it came back negative for an infection.It has not been determined if the cup contributed to the bladder pain.

• Brand Name: SAALT
• Type of Device: REGULAR BLUE
• Manufacturer (Section D): SAALT, LLC; 6148 n discovery way; ste. 175; boise ID 83713
• Manufacturer Contact: 6148 n discovery way; ste. 175; boise, ID 83713
• MDR Report Key: 11209237
• MDR Text Key: 228172544
• Report Number: 3014276660-2020-02500
• 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: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: REGULAR BLUE
• Device Lot Number: 0919RB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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