MAUDE Adverse Event Report: TOSAMA D.O.O. CORA; UNSCENTED MENSTRUAL TAMPON

Model Number	LIGHT
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	12/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A user contacted support indicating that shortly after inserting a light absorbency tampon at the end of their period they started having dizziness, anxiety, and feeling like they were going to pass out.Later they had chills throughout their entire body which caused them to shake aggressively.They then started getting a fever and had symptoms of hypotension.They realized they started feeling terrible after putting a tampon in so they immediately took it out and within 20 minutes all symptoms were gone.The tampon was in for less than 2 hours total.The user stated that they had never experienced this set of symptoms before with a period product, it was not their first time using a tampon, there were no pre-existing medical conditions/allergies/drugs that might have caused this to occur.The user did not seek medical attention because the symptoms went away.Although unconfirmed, these symptoms are consistent with the onset of tss and therefore are being reported as an adverse event.
Additional Manufacturer Narrative
Information from this event will be included in our complaint and mdr trend analysis.

• Brand Name: CORA
• Common Device Name: UNSCENTED MENSTRUAL TAMPON
• Manufacturer (Section D): TOSAMA D.O.O.; vir, saranoviceva cesta 35; si-1230; domzale, 1230 ; SI 1230
• Manufacturer (Section G): TOSAMA D.O.O.; vir, saranoviceva cesta 35; 1230, domzale, 1230 ; SI 1230
• Manufacturer Contact: janez obreza ; vir, saranoviceva cesta 35; 1230, domzale, 1230 ; SI 1230
• MDR Report Key: 19328641
• Report Number: 3007740671-2024-00001
• Device Sequence Number: 2972566
• Product Code: HEB
• UDI-Device Identifier: 00850003218328
• UDI-Public: 00850003218328
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 05/15/2024

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: LIGHT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Sex: Female