MAUDE Adverse Event Report: SAALT, LLC SAALT; DUO PACK

Model Number DUO PACK

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Unspecified Infection (1930)

Event Date 03/13/2019

Event Type  malfunction  

Event Description

Customer contacted saalt on (b)(6) 2019 notifying us that she had an on-going issue with her cup.She stated that she had started getting infections after using the cups and noted she was not allergic to silicone.We followed up asking information about how she was cleaning and sanitizing her cup to learn more and she stated that she usually boiled her cups in baking soda, which ended up creating a reoccurring white residue every month.She went to the doctor due to her infection and her doctor advised that the infection was bacterial vaginosis and treated with antibiotics.Following continued conversation with the customer about proper sanitizing techniques and advising not to use baking soda, she let us know she has occasionally had the cups sit in vinegar and peroxide for 1 minute and also allowed them to sit in cornstarch overnight.We requested that she send the cups to our office and we offered her replacement cups, as well as provided education on how to sanitize her cups moving forward to avoid infection and residue on the cups.From the investigation, we determined the infection and irritation came from use of baking soda while cleaning the cup.

• Brand Name: SAALT
• Type of Device: DUO PACK
• Manufacturer (Section D): SAALT, LLC; 6149 n. meeker place; ste. 110; boise ID 83713
• Manufacturer Contact: danielle burden ; 6149 n. meeker pl.; ste. 110; boise, ID 83713 ; 8013682646
• MDR Report Key: 9649591
• MDR Text Key: 205322486
• Report Number: 3014276660-2020-20006
• 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: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DUO PACK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 01/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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