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

Model Number 02Tampons-303

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

Patient Problem Toxic Shock Syndrome (2108)

Event Date 05/22/2020

Event Type  Injury  

Manufacturer Narrative

Information from this event will be included in our complaint and mdr trend analysis.

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.No injury or medical intervention needed was reported.

• Brand Name: CORA
• Type of Device: UNSCENTED MENSTRUAL TAMPON
• Manufacturer (Section D): TOSAMA D.O.O.; saranoviceva cesta 35, vir; domzale, 1230 ; SI 1230
• Manufacturer Contact: janez obreza ; saranoviceva cesta 35; vir; domzale 1230 ; SI 1230
• MDR Report Key: 10371813
• MDR Text Key: 205113442
• Report Number: 3007740671-2020-00001
• Device Sequence Number: 1
• Product Code: HEB
• UDI-Device Identifier: 00850373007379
• UDI-Public: 00850373007379
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 02Tampons-303
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other