MAUDE Adverse Event Report: THE FLEX COMPANY SOFTDISC; DISPOSABLE MENSTRUAL DISC

Model Number	60009
Medical Device Problem Codes	Difficult to Remove (1528); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported going to urgent care for assistance with removal of softdisc disposable menstrual disc.The disc had been inserted for 18 hours when the customer sought assistance.The customer stated that the physician's assistant (pa) struggled to remove the disc.The pa unsuccessfully tried removing the disc with a speculum and forceps before then pushing on the customer's abdomen and successfully removing the disc digitally.The pa determined the disc was suctioned to the customer's cervix.The customer stated she felt "internally and externally bruised" from the assisted removal, but also said she did not have pain/discomfort post removal.The customer was not prescribed any medication.The customer was advised by flex to discontinue use of all internally worn flex products until they can follow up with their primary healthcare provider to discuss their experience.The submission of this report is not an admission by the company that the use of the device in question caused or contributed to the customer event.

• Brand Name: SOFTDISC
• Common Device Name: DISPOSABLE MENSTRUAL DISC
• Manufacturer (Section D): THE FLEX COMPANY; 318 lincoln blvd; #204; venice CA 90291
• Manufacturer (Section G): SOUTHMEDIC INC; 50 alliance blvd; barrie, on L4M5K 3; CA L4M5K3
• Manufacturer Contact: cole rocca ; 318 lincoln blvd; #204; venice, CA 90291 ; 4242092711
• MDR Report Key: 21076519
• Report Number: 3012971814-2025-00002
• Device Sequence Number: 15178034
• Product Code: HHE
• UDI-Device Identifier: 00851906007033
• UDI-Public: 00851906007033
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 60009
• Device Lot Number: 1009746
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Age: 52 YR
• Patient Sex: Female