MAUDE Adverse Event Report: SAALT, LLC SAALT; SAALT CUP SMALL PINK

Model Number SMALL PINK

Device Problems Difficult to Remove (1528); Suction Problem (2170); Patient Device Interaction Problem (4001)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 07/24/2019

Event Type  Injury  

Event Description

The customer was a first time cup user.She attempted to remove her cup first thing in the morning after having worn it for 8 hours in bed.She could not reach the base of the cup to remove it and tried multiple positions over approximately 2 hours.Between attempts she rested by laying back down and watching multiple videos about menstrual cup use.After these videos and being able to feel the base of the cup, the customer then attempted to pinch the base of the cup to remove for approximately another hour but experienced hand cramps and was unable to pinch the base of the cup.The customer did not use any of the resources mentioned by saalt in ifu.The customer became nervous and went to urgent care to seek assistance.The nurse practitioner was able to remove the cup quickly and easily.The np did mention that the cup had created suction on the cervix but made no mention of the customer having a high or low cervix.The cup was disposed of at the urgent care center.The device was not returned for evaluation as it was discarded after removal.The reported event is addressed in the labeling.The dhr was not consulted as the customer did not provide serial or lot information.This event is not a new or novel event, and based on the severity of the individual occurrence, no capa is required at this time.Additional actions which may include capa activity and/or escalation of noted issues will be taken if an outlying trend for an event is noted.The reported event could not be confirmed as the device was not returned for evaluation.The most likely root cause of the reported event could not be conclusively determined.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." 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 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: SAALT CUP SMALL PINK
• Manufacturer (Section D): SAALT, LLC; 6148 n. discovery way; suite 175; boise, id
• Manufacturer Contact: danielle burden ; 6148 n. discovery way; suite 175; boise, id ; 3682646
• MDR Report Key: 10188725
• MDR Text Key: 201046471
• Report Number: 3014276660-2020-20021
• 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: Other
• Type of Report: Initial
• Report Date: 05/29/2020

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: SMALL PINK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 06/24/2020
• 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