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

Model Number 02Tampons-315

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

Patient Problems Bacterial Infection (1735); Abnormal Vaginal Discharge (2123)

Event Date 02/10/2021

Event Type  Injury  

Event Description

A mother contacted support indicating that her minor daughter experienced a tampon unraveling during removal.The tampon was in place for less than 4 hrs and was dry upon removal due to light flow.The absorbency used during the event was unknown, and the drawer from which the tampon was drawn by the user had a mix of multiple brands in it.The user was taken to a gynecologist where the remaining fibers were removed from her vagina.After a follow-up appointment with the gynecologist the user was prescribed two courses of two different antibiotics, type and route of administration were not specified.

• 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: 11866370
• MDR Text Key: 252400990
• Report Number: 3012097557-2021-00001
• Device Sequence Number: 1
• Product Code: HEB
• UDI-Device Identifier: 00850003218328
• UDI-Public: 00850003218328
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 05/21/2021,05/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 02Tampons-315
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2021
• Distributor Facility Aware Date: 02/10/2021
• Event Location: Home
• Date Report to Manufacturer: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15 YR