MAUDE Adverse Event Report: SAALT, LLC SAALT; MENSTRUAL CUP

Model Number REGULAR BLUE

Device Problems Difficult to Remove (1528); Patient-Device Incompatibility (2682)

Patient Problems Fever (1858); Pain (1994); Toxic Shock Syndrome (2108); Device Embedded In Tissue or Plaque (3165)

Event Date 09/23/2019

Event Type  malfunction  

Event Description

On (b)(6) 2020, saalt's customer service team received an email from a customer alerting them that the customer had been diagnosed with toxic shock syndrome (tss) after using a saalt cup.Saalt immediately set up a call to speak with the customer the following day.(b)(6) purchased the saalt cup in the (b)(6) of 2019.She was able to use the cup with very little difficulty for two periods.Insertion was very easy for her.She did mention that removal was somewhat difficult for her.She had to reach in and grab the base of the cup and squeeze it to break the suction, which is not uncommon and is how the device is designed to function.Medical intervention: (b)(6) stated that on the morning of (b)(6) 2019 she woke up and went for a 2-mile run and felt normal.She then got ready and went to school.She felt fine until about lunch time when she started feeling, as she described, 'weird and dizzy'.By her last class period her stomach and lower back were in pain and she felt lightheaded and shaky.She had what she described as a migraine headache and felt like she needed to go to sleep.She told a friend that something was wrong with her and she went home.Her first thought was that maybe it was toxic shock syndrome, so she removed her cup at home.(b)(6) called her mom who came home to be with her.Within an hour of her mom being home she reported that her temperature rose to 103 degrees fahrenheit.Her mother gave her tylenol, motrin and another medication to lower her temperature, but it remained elevated.Within another 2-3 hours she reported feeling limp and weak.Her mom decided that it was time to get medical assistance, so she took (b)(6) to a clinic.At the clinic workers made two attempts to take (b)(6) blood pressure on one arm and one time on the other side.Her blood pressure was unreadable, which (b)(6) said the nurse attributed to a potentially faulty blood pressure machine.The clinician listened to her symptoms and was unable to make a diagnosis.They did a blood test and (b)(6) said that after seeing the results the clinician told her that she could either take an ambulance or drive, but she needed to get to the hospital.Her mom drove her to the hospital.When she arrived at the hospital, more blood tests were completed, and the doctors were still unable to make a diagnosis.Her blood pressure continued to drop, and the doctors were concerned because her white blood cell count was elevated.(b)(6) was admitted to the icu that night.She remained there for 4 days where she was treated with antibiotics.While in the icu she was diagnosed with toxic shock syndrome.She was discharged on (b)(6).Upon her release (b)(6) was instructed to continue oral antibiotics and to eat high fat foods if she was able.After several days at home she returned to school for one day.After feeling ill again, she went back to the doctor and said she was diagnosed with a clostridium difficile infection from the heavy antibiotics.She was then prescribed another medication that she had to take for an additional two weeks.(b)(6) reported that none of her medical providers had ever treated a patient with tss before, aside from one doctor at the icu who had seen one other case.Her ob/gyn recommend that she avoid all inserted menstrual products at a minimum for several years, or to plan to never use them again.She has continued to experience some adverse symptoms during her menstrual cycles since being treated for toxic shock syndrome and her ob/gyn has prescribed her an inserted rod birth control in an attempt to stop her periods.At a follow-up appointment (b)(6) doctor did conduct a vaginal exam and did not tell her about any visible concerns.At the time of this report, she is still recovering and she still experiences fatigue after physical exertion.Her doctors let her know that her body went through a very difficult experience and it will take time to completely recover.Cup use: (b)(6) had never used another menstrual cup prior to the saalt cup.She wore the cup for two full cycles without any symptoms.She only experienced symptoms at the end of her third cycle.She was wearing the cup for 6-8 hours before removal and emptying.When at home she would wash the cup with hot water and at school she would remove and wipe with toilet paper.(b)(6) would store the cup in a cotton pouch in between cycles.The saalt cup was the only menstrual product she was using at the time.When asked if that cycle was different at all she mentioned that she may have felt slightly more cramping, but that was all.When asked if there was anything different about the cup that cycle, she said that she did notice some staining and that there was "stuff" in the holes that she couldn't get out.Follow up: saalt requested to have the device returned by the customer and it was received in the mail on january 24th, 2020 sealed in an airtight containment bag provided to the customer by saalt.A visual and physical inspection of the device did not reveal any sign of damage or defects.There was no tearing, abrasion or other nonconformity visible on the cup and the cup was folding and flexing as expected and as designed.Based on the inspection of the cup, there is no reason to believe that the device malfunctioned or did not work as intended.There was staining that was visible on the device, particularly near the top of the cup around the upper ring and cuff and some biological residue (presumably menses from the customer) was still inside the air holes of the cup.Saalt has made 3 requests to have the medical records from the event released for review.The customer has not authorized the release of medical records to saalt.Corrective actions saalt, llc reviewed the current instructions for use (ifu) for the cleaning of the device and general toxic shock syndrome information.Although the ifu already contained information on how to properly clean the device, including boiling it between cycles, the ifu was updated to make these sections more clear by directly instructing the user to boil the device in more than one location in the ifu and by bolding the language and putting it in a different color.We also added visual emphasis to make the section that describes the symptoms of tss more readily noticeable to the reader by putting the text in bold.These changes are also being made to saalt's website to update the instructions page, the learn page and the faq pages and any other pages that reference cleaning or have information regarding tss.

• Brand Name: SAALT
• Type of Device: MENSTRUAL CUP
• Manufacturer (Section D): SAALT, LLC; 6149 n meeker pl ste110; boise ID 83713
• Manufacturer Contact: danielle burden ; 6149 n meeker pl suite 110; boise, ID 83713 ; 8013682646
• MDR Report Key: 9644617
• MDR Text Key: 221299935
• Report Number: 3014276660-2019-20053
• 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: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• 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: 0718RB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Date Manufacturer Received: 01/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 17 YR