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

Model Number BLUE SMALL

Device Problems Difficult to Remove (1528); Patient Device Interaction Problem (4001)

Patient Problems Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/29/2020

Event Type  Injury  

Event Description

Customer emailed saalt on 7/1/2020 to explain that they had to seek medical care to have their cup removed.Customer said they followed saalt's instructions and inserted the cup high enough to where they couldn't reach it for removal.She said a doctor removed the cup with forceps.Saalt emailed back requesting additional information on 7/1/2020.On 7/2/2020 - customer stated that when she went to her appointment the cup had been inserted for 24 hours due to appointment availability.This was her first time ever wearing a menstrual cup.Before attempting to remove the cup initially she had been upright and moving around.When she tried to remove the cup she could feel the stem, but felt that it was misplaced.Customer claimed she reached her fingers into her vaginal canal to her cervix and still could not grab the cup.Customer tried squatting, gently bearing down and sitting on the toilet to remove cup.For the first attempt at removing the cup, it had been in for 1 hour and 30 min.User tried for 1 hour 30 min to remove the cup.She stopped trying and decided to go to sleep.The next morning the cup had not changed position.She exercised and tried again, but was still not able to remove the cup.First the user tried to have the nurse at her work help her remove the cup after it had been in for 14 hours, and the nurse also could not reach the base of the cup.Customer went to doctor later to get cup removed with forceps.Customer claimed the position of the cup was still the same.Customer used the saalt website instructions and online video for tips on removal.The doctor did not mention anything peculiar about customer's anatomy, but did claim she had a high cervix.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: BLUE SMALL
• Manufacturer (Section D): SAALT, LLC; 6148 n. discovery way; ste. 175; boise ID 83713
• Manufacturer Contact: danielle burden ; 6148 n. discovery way; ste. 175; boise, ID 83713 ; 8013682646
• MDR Report Key: 10856188
• MDR Text Key: 216949205
• Report Number: 3014276660-2020-00014
• Device Sequence Number: 1
• Product Code: HHE
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BLUE SMALL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 35 YR