MAUDE Adverse Event Report: SAALT, LLC SAALT; SAALT CUP DUO PACK

Model Number SMALL PINK AND BLUE REGULAR

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Skin Irritation (2076); Reaction (2414)

Event Date 04/27/2020

Event Type  Injury  

Event Description

Customer reached out on 4/24/2020 letting us know she has used a saalt cup for the last year without any issues, but her dog chewed her old one so she ordered a duopack a few weeks ago.She had a lot of discomfort (itchiness, pain, swollen, irritation) and felt the cup was different in some way.Saalt responded on 4/27/2020 and asked for more information about her experience and she notified us that she would be going to the doctor since sheets of skin were coming out of her vagina due to the chaffing and pain she was experiencing.Her doctor believes the irritation was from chaffing and a possible lack of blood flow to the area which may have caused the inner lining of her vagina to "die." she was given antibiotics and the doctors determined there was no other infection or bacterial issue by testing her urine.She noted she did not boil the cup prior to using it for the first time and washed it with method brand unscented soap and water.The device was not returned for evaluation as it was not requested to be returned.The reported event is addressed in the labeling.The device history record (dhr) for lot # 0119sp and 0219rb was reviewed.There were no deviations, errors, omissions, or non-conformities that were noted to be associated with the reported device.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 prior to first use: "boil your cup in water for 4-5 min (no more than 7 min).Use tongs or a wire whisk to ensure the cup doesn't touch the bottom of the pot.".

• Brand Name: SAALT
• Type of Device: SAALT CUP DUO PACK
• 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: 10856577
• MDR Text Key: 216825949
• Report Number: 3014276660-2020-20091
• 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: 06/25/2020

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: SMALL PINK AND BLUE REGULAR
• Device Lot Number: 0119SP AND 0219RB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2019
• 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: 23 YR