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

Model Number REGULAR BLUE

Device Problem Difficult to Remove (1528)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 04/26/2020

Event Type  Injury  

Event Description

Customer had been wearing the cup for about 5 hours before she began to try removing it.She tried all of the tips on our website, instructions, but was not able to remover her cup.She decided to go to urgent care to have her cup removed.The doctor removed her cup with forceps and threw the cup away on sight.The device was not returned for evaluation as it was discarded after removal.The reported event is addressed in the labeling.There were no deviations, errors, omissions, or non-conformities that were noted to be associated with the reported device.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.".

• Brand Name: SAALT
• Type of Device: REGULAR BLUE
• Manufacturer (Section D): SAALT, LLC; 6148 n. discovery way; ste. 175; boise, id
• Manufacturer Contact: danielle burden ; 6148 n. discovery way; ste. 175; boise, id ; 3682646
• MDR Report Key: 10189006
• MDR Text Key: 201052175
• Report Number: 3014276660-2020-20089
• 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: 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: 04/27/2020
• 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