MAUDE Adverse Event Report: SAALT SAALT; REGULAR BLUE

Model Number REGULAR BLUE

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/17/2020

Event Type  Injury  

Event Description

Customer emailed saalt on 12/17/2020 to explain that they chose to seek medical care to have their saalt cup removed after they struggled to remove it on their own.They said that the stem of their cup was too short for them to reach and that the cup got stuck in their vagina.Saalt asked additional questions about the customer's experience including the type of cup she was using, if it was her first time using a cup, how long the cup had been inserted prior to seeking help, what her removal methods were, whether the doctor said anything about her cervix height or anatomy that would have made it more difficult to reach the cup, and we requested photos of the cup.Customer responded on 12/27/2020 and noted this was the first time they had used a menstrual cup.She was able to pinch the base of the cup, but was not able to release the suction seal to remove the cup on her own.She had not worn the cup long, and just inserted to test it out and then struggled to remove it.The doctors noted the cup may have been too large for her and they gave her the cup back after removal.Instructions for use (ifu) states to remove the cup: "consider removing your cup in the shower or while sitting on a toilet.Always pinch the grip rings at the base of the cup to break the seal (don't pull on the stem alone).Wiggle your cup back and forth while holding the grip rings and keep your cup upright as you pull it past your labia to avoid spilling." it also states that "the cup can move higher if a good seal isn't formed when first inserted, but it will not get lost in the vagina.Walk around and wait 30 minutes and try again, or use your pelvic muscles to bear down on the cup, pushing it lower.Squatting in the shower can also help.Once in reach, pinch the lower base of cup to break the seal, and then gently pull it out." the ifu further states that "uterine lining can sometimes get stuck inside the cup and block the suction holes making it difficult to remove the cup.".

• Brand Name: SAALT
• Type of Device: REGULAR BLUE
• Manufacturer (Section D): SAALT; 6148 n discovery way; ste. 175; boise ID 83713
• Manufacturer Contact: 6148 n discovery way; ste. 175; boise, ID 83713
• MDR Report Key: 11135736
• MDR Text Key: 226009314
• Report Number: 3014276660-2020-02344
• 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: 01/07/2021

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 BLUE
• Device Lot Number: 0719RB
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/07/2021
• 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: 20 YR