MAUDE Adverse Event Report: SAALT, LLC SAALT; SOFT REGULAR GREY

Model Number SOFT REGULAR GREY

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 01/22/2020

Event Type  malfunction  

Event Description

Customer contacted us on 1/22/2020.She said her saalt soft regular had arrived the day before and she inserted her cup the evening of (b)(6) 2020.When she woke up the next morning she tried to remove her cup and found that it had moved up higher in her vaginal canal.She said she then went to the obgyn to have it removed.She was requesting to return her cup.We sent her our response email with a list of questions to gather more details and offered a replacement cup or a refund.1/29/2020 saalt did not receive a response from the customer, so saalt reached out to offer a replacement/refund again.2/5/2020 saalt did not receive a response from the customer, so saalt reached out to offer a replacement/refund a third time.Saalt received a response on 2/6/2020 and told us she got up on (b)(6) 2020, showered, walked around and still could not reach her cup for removal.The cup had been inserted for 8 hours before she had the cup removed at the doctor.She looked at saalt's instructions, videos, and online articles, but did not email customer service directly for tips before seeking medical care.The customer still has not noted if she wants a replacement cup or refund.

• Brand Name: SAALT
• Type of Device: SOFT REGULAR GREY
• Manufacturer (Section D): SAALT, LLC; 6149 n. meeker place; ste. 110; boise, id
• Manufacturer Contact: danielle burden ; 6149 n. meeker place; ste. 110; boise, id ; 3682646
• MDR Report Key: 9720794
• MDR Text Key: 205320896
• Report Number: 3014276660-2020-20061
• 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: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SOFT REGULAR GREY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2020
• 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