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

Model Number SMALL GREEN

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/07/2021

Event Type  Injury  

Event Description

Customer left a review on our website explaining that their iud came out when they were removing their cup.Saalt emailed the customer and requested additional information about their experience including the type of cup they were using, their removal techniques, how long their iud had been inserted, how long their cup had been inserted prior to the iud expelling, and we asked for photos of the cup.Customer responded on (b)(6) 2021 and explained this was their first time using a menstrual cup.They stated their iud strings were cut short but did not discuss cup use with a doctor prior to use.Customer had worn cup about four hours before removing, and they felt like they had released the seal with their finger before removing the cup.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 GREEN
• 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: 11209235
• MDR Text Key: 228172223
• Report Number: 3014276660-2021-02630
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SMALL GREEN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2021
• 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