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

Model Number SMALL PINK

Device Problems Break (1069); Difficult to Remove (1528); Material Split, Cut or Torn (4008)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 07/20/2018

Event Type  Injury  

Event Description

Customer reached out on 7/20/2018 notifying us that the stem of the cup was torn off and she could not remove the cup without it.She went to the doctors office for removal.We responded notifying her that we would refund the cost of the cup and also provided tips for removal noting that the stem is not to be used as a pull tab, but rather a tool to find the base of the cup for removal and that the stem should never be pulled on alone.We offered to send her a new cup, as well, but never received any customer response after 7/24/2018.

Event Description

It was reported by the customer that the stem broke off and the menstrual cup was "stuck".The customer went to the doctor to the have the cup removed.No further issues were reported after removal of the device.Upon follow up, the customer was offered additional removal tips and education including the website faqs, illustrations, videos, pictures and referral to the saalt cup academy facebook group.

Manufacturer Narrative

Corrected data: b5: the device was not returned for evaluation as it was discarded after removal.The reported event is addressed in the labeling.Although the device lot number was provided, dhr results are still pending.Dhr will be submitted in a follow-up report.The reported event of "stem break" is a known issue and has been investigated under capa: 003.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.The instructions for use (ifu) state: "to remove the cup, use the stem as a guide to locate the grip rings and break the suction seal by pinching the base of the cup with thumb and index finger.The stem is not a pull tab, do not pull hard on the stem to remove."the ifu further states to "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." 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: SMALL PINK
• Manufacturer (Section D): SAALT, LLC; 6149 n meeker place; suite 110; boise, id ID 83713
• MDR Report Key: 9644637
• MDR Text Key: 205321960
• Report Number: 3014276660-2020-20003
• Device Sequence Number: 1
• Product Code: HHE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SMALL PINK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention