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

Model Number REGULAR BLUE

Device Problems Break (1069); Difficult to Remove (1528); Patient Device Interaction Problem (4001)

Patient Problems Therapeutic Effects, Unexpected (2099); Foreign Body In Patient (2687)

Event Date 01/31/2020

Event Type  Injury  

Event Description

Customer reached out to us on (b)(6) 2020 letting us know she had difficulty removing her cup after the stem broke off the cup.She has been a saalt cup user for a couple of years.She had tried to avoid using the stem for removal, but claimed that she occasionally needed to pull the stem.When the stem broke, she tried various removal techniques to move the cup down without success.She asked her husband for help, as well, and he was unable to remove the cup.She ended up going to the doctor to have the cup removed and they gave her the cup back.We offered a replacement cup at the customer's request so that she can try the cup again.The device was not returned for evaluation.The reported event is addressed in the labeling.The device history record (dhr) was not reviewed.The 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 (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." regarding the broken stem, the ifu states: "the stem is not a pull tab, do not pull hard on the stem to remove." "do not pull on the stem." "always pinch the grip rings at the base of the cup to break the seal (don't pull on the stem alone).".

• Brand Name: SAALT
• Type of Device: REGULAR BLUE MENSTRUAL CUP
• 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: 10188776
• MDR Text Key: 197802384
• Report Number: 3014276660-2020-20065
• 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: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• 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
• Date Manufacturer Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR