MAUDE Adverse Event Report: MENSTRUAL MATES, INC DBA SUNNY MENSTRUAL MATES, INC DBA SUNNY; SUNNY CUP + APPLICATOR

Model Number	SUNAC011PEGI01
Medical Device Problem Codes	Difficult to Remove (1528); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device was manufactured to all required specifications.After a review of the maude database, this appears to be an issue that is seen often with menstrual cups.Ongoing research will be done to determine if there are ways to prevent this event from happening in the future.
Event or Problem Description
On january 6, 2026 sunny was made aware of a customer complaint via email.The customer claimed that while using the sunny cup + applicator, their cup became stuck and they had to seek medical care at urgent care to have it removed.This customer also noted that they have physical constraints, including hypermobility issues and a high cervix, that make reaching the inserted cup difficult.Once sunny became aware of this event, they reached out to the customer 2 times (january 7, 2026, and january 14, 2026) for more information.The customer has not yet responded.No further information about the event is available.Sunny believes the instructions given in the instructions for use are an adequate directive for the removal of the menstrual cup.The ifu states: "locate the base of your cup" "if you cannot reach it, gently push like you're having a bowel movement" "use the stem as a guide until you can reach the base of your cup.Pinch the base of your cup to break the seal.With the base pinched, gently pull down to remove your cup." the submission of this report is not an admission by the company that the use of the device in question caused or contributed to this event.

• Brand Name: MENSTRUAL MATES, INC DBA SUNNY
• Common Device Name: SUNNY CUP + APPLICATOR
• Manufacturer (Section D): MENSTRUAL MATES, INC DBA SUNNY; 16192 coastal highway; lewes DE 19958
• Manufacturer (Section G): ALBRIGHT TECHNOLOGIES, INC; 30 patriots circle; leominster MA 01453
• Manufacturer Contact: danielle burden ; 16192 coastal highway; lewes, DE 19958 ; 8013682646
• MDR Report Key: 24180125
• Report Number: 3027115741-2026-00002
• Device Sequence Number: 10016878
• Product Code: HHE
• UDI-Device Identifier: 00860009638617
• UDI-Public: (01)00860009638617(10)00005
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K233361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: SUNAC011PEGI01
• Device Lot Number: 102623
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female