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

Model Number REGULAR BLUSH

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/23/2020

Event Type  Injury  

Event Description

Customer left a review on (b)(6) explaining that their iud was dislodged when they removed their menstrual cup.Saalt left a comment and asked the customer to email them so saalt can request some additional information about the customer's removal techniques, cup mold identifying number, and lot number on the packaging.Saalt attempted to contact the customer three times without any response.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." 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: REGULAR 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: 11209230
• MDR Text Key: 228172024
• Report Number: 3014276660-2020-02428
• 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: REGULAR BLUSH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2020
• 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