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

Model Number REGULAR BLUE

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 11/17/2020

Event Type  Injury  

Event Description

Customer reached out to saalt via email to explain that their cup was difficult to remove and they felt it necessary to visit the er to have the cup removed.The cup has been in for 13 hours when customer tried to remove it herself.She attempted to remove it for 1.5 hours before she decided to go to the emergency room.Saalt requested additional information about the customer's removal techniques, removal resources they sought out, the type of cup they were using, the cup mold identifying number, and the lot number on the packaging.Saalt also requested a photo of the cup.Customer stated that she has an abnormal shaped vaginal canal and abnormal reproductive organs and feels as though she should not have tried inserting the cup in the first place.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: bill briley ; 6148 n. discovery way; ste. 175; boise, ID 83713
• MDR Report Key: 10943145
• MDR Text Key: 219498501
• Report Number: 3014276660-2020-01546
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: REGULAR BLUE
• Device Lot Number: 0919RB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2020
• 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