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

Model Number REGULAR BLUE

Device Problem Difficult to Remove (1528)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/28/2020

Event Type  Injury  

Event Description

Customer contacted saalt to notify us that after trying her cup for the first time, she required medical assistance to remove it at the er.Saalt sent follow up questions to learn more about the situation.Customer responded explaining that it was the first time they had used a menstrual cup.They attempted to remove the cup while sitting, standing and squatting and also consulted articles online and (b)(6) videos before seeking medical care.The customer never contacted saalt while they were attempting to remove their cup.Customer also provided a photo of their receipt, and photos of the cup/packaging.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, LLC; 6148 n. discovery way; ste. 175; boise ID 83713
• Manufacturer Contact: bill briley ; 6148 n. discovery way; ste. 175; boise, ID 83713
• MDR Report Key: 10856237
• MDR Text Key: 216838268
• Report Number: 3014276660-2020-00618
• 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: 11/17/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/29/2020
• Initial Date FDA Received: 11/17/2020
• 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: 19 YR