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

Model Number REGULAR BLUE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Irritation (1941); Pain (1994); Burning Sensation (2146)

Event Date 05/10/2020

Event Type  Injury  

Event Description

Customer contacted saalt to note that she had irritation and soreness while using her cup that was causing a "burning pain" after removal and chose to seek medical advice.After visiting the doctor, she said that was just a small vaginal tear the size of a grain of salt from inserting and removing her cup.Doctors said there was no infection present, just irritation from wearing the cup.Customer had been using the cup for 3 cycles before this happened.

• 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: 10856639
• MDR Text Key: 216825181
• Report Number: 3014276660-2020-20100
• Device Sequence Number: 1
• Product Code: HHE
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• 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: 05/10/2020
• 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
• Patient Age: 25 YR