MAUDE Adverse Event Report: SAALT, LLC SAALT; SMALL PINK

Model Number SMALL PINK

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

Patient Problem Unspecified Infection (1930)

Event Date 05/15/2020

Event Type  Injury  

Event Description

Customer experienced no symptoms of bladder or urethral irritation, nor a halted or weakened urine stream when using the cup.However, on her last day of her cycle, she noticed she had developed a uti and sought medical care.Her doctor recommened for her to stop using the cup.

• Brand Name: SAALT
• Type of Device: SMALL PINK
• 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: 10856788
• MDR Text Key: 216827545
• Report Number: 3014276660-2020-20104
• 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: 07/29/2020

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
• Device Lot Number: 0519SP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 17 YR