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

Model Number SAALT REGULAR

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

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 08/05/2019

Event Type  Injury  

Event Description

The customer inserted the cup saturday morning and attempted to remove it after 12 hours.Feeling like she couldn't get both fingers inserted to pinch the cup, she was unsuccessful.She looked for advice on the saalt (b)(6) group on sunday morning.After receiving several tips she tried to remove the cup and was again unsuccessful.The customer went to the doctor on monday morning to have the cup removed.The doctor was able to remove the cup after puncturing it.The cup was discarded at the doctor's office.The device was not returned for evaluation as it was discarded after removal.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 SIZE
• 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: 10188733
• MDR Text Key: 201040333
• Report Number: 3014276660-2020-20024
• 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: 08/09/2020

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: SAALT REGULAR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention