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

Model Number SMALL BLUSH

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/14/2021

Event Type  Injury  

Event Description

Customer posted in saalt's (b)(6) group describing that their iud came out while removing their cup.Saalt commented on the customer's (b)(6) post and asked them to email us directly.They emailed us directly on 1/14/2021 and we requested additional information about their experience.Customer responded with the information requested and provided their dob, phone number, address, order number, and a photo of their cup.They said that their cup strings were cut to 2 inches and their medical provider said they would be fine using the cup and iud together.She said she always breaks the seal of the cup during removal.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.".

• Brand Name: SAALT
• Type of Device: SMALL BLUSH
• 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: 11209249
• MDR Text Key: 228166225
• Report Number: 3014276660-2021-02711
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SMALL BLUSH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 01/21/2021
• 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: 23 YR