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

Model Number REGULAR BLUE

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/06/2021

Event Type  Injury  

Event Description

Customer emailed us to explain that during her most recent period, her iud partially came out when she removed her cup one day.She said she had been using the cup since summer of 2019 and had her iud inserted in 2018.She said she spoke with her doctor about using the cup with her iud and said the doctor approved.Saalt requested additional information about her experience.Customer responded with requested information and provided a photo of the cup, where she purchased her cup, their dob, and said that their iud strings were not cut short.Instructions for use (ifu) states to consult your physician before using your cup with an iud.We have since updated our instructions to add the language "be sure to break the seal before removing your saalt cup to avoid dislodging your iud." submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

• 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: 11209245
• MDR Text Key: 228171642
• Report Number: 3014276660-2021-02726
• 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: 01/21/2021

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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2021
• 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
• Patient Age: 25 YR