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

Model Number GREY REGULAR

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 05/26/2020

Event Type  Injury  

Event Description

Customer said it was too hard to reach the cup and chose to seek medical care to assist with removing the cup.The cup had been inserted for 11 hours before attempting to remove it and she watched (b)(4) videos to try and find more tips to help with removal.Customer had used other menstrual cups in the past, but this was her first time using a saalt cup.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: GREY REGULAR
• 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: 10856952
• MDR Text Key: 216827318
• Report Number: 3014276660-2020-20109
• 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: 10/01/2020

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: GREY REGULAR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2020
• 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