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

Model Number REGULAR BLUE

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/05/2021

Event Type  Injury  

Event Description

Customer left a review on the saalt website on 1/8/2021 saying that they chose to seek medical assistance to have their cup removed because they could not remove it alone.They said they purchased the regular size saalt cup, and that the suction was too strong for them to break the seal.The er doctors were then able to remove her cup.Saalt emailed her on 1/11/2021 to ask for additional details about her experience.Customer responded with details about their experience.She said the cup had been inserted for 12 hours prior to her removal attempts.It was not her first time using a menstrual cup.She could not reach the base of the cup to pinch and break the seal for removal.She went to urgent care and the doctors there were unable to remove her cup with their tools (speculum and forceps).Then, she went to the emergency room and a nurse was able to reach her finger up to the rim of the cup and break the seal for removal.The cup was disposed of immediately.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." submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

• Brand Name: SAALT
• Type of Device: REGULAR BLUE
• Manufacturer (Section D): SAALT, LLC; 6148 n discovery way; ste. 175; boise ID 83713
• Manufacturer Contact: 6148 n discovery way; ste. 175; boise, ID 83713
• MDR Report Key: 11209248
• MDR Text Key: 228153993
• Report Number: 3014276660-2021-02659
• 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: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• 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: 01/05/2021
• 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: 30 YR