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

Device Problems Unraveled Material (1664); Patient-Device Incompatibility (2682)

Patient Problem Toxic Shock Syndrome (2108)

Event Date 05/22/2020

Event Type  Injury  

Event Description

Mid-cycle, user inserted a new tampon.Within an hour after insertion the user began to feel extremely sick.Symptoms: extreme headache, dizziness, sharp abdominal pain, and body aches.User left work and removed tampon.Upon removal the tampon was unraveling and had a "hard dark plastic thing inside the cotton" which was discovered after picking the tampon apart.Within 10 minutes of removing tampon the user's abdominal pain subsided and by the end of the day all symptoms were gone.Because of covid, user consulted a healthcare provider via telemedicine and from the symptoms the healthcare provider determined that the user more than likely experienced tss.

• Brand Name: CORA
• Type of Device: TAMPON
• Manufacturer (Section D): TOSAMA D.O.O.; saranoviceva cesta 35; vir, domzale 1230 ; SI 1230
• MDR Report Key: 18640368
• MDR Text Key: 334544747
• Report Number: 3012097557-2020-00001
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2020,05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/22/2020
• Event Location: Home
• Date Report to Manufacturer: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female