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

Lot Number UNKNOWN

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  

Manufacturer Narrative

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

Event Description

A mother contacted support indicating that her minor daughter experienced a tampon unraveling during removal.The tampon was in place for <4 hrs and was dry upon removal due to light flow.The actual brand, type, absorbency and lot number of menstrual tampon 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 gynaecologist where the remaining fibers were removed from her vagina.After a follow-up appointment with the gynaecologist the user was prescribed two courses of two different antibiotics, type and route of administration were not specified.There is no clear indication that our device is connected with the actual event/prescription of antibiotics by medical professional.

• Brand Name: CORA
• Type of Device: UNSCENTED MENSTRUAL TAMPON
• Manufacturer (Section D): TOSAMA D.O.O.; saranoviceva cesta 35, vir; si-1230; domzale, 1230 ; SI 1230
• Manufacturer Contact: janez obreza ; saranoviceva cesta 35; vir, si-1230; domzale, 1230 ; SI 1230
• MDR Report Key: 11982938
• MDR Text Key: 255662908
• Report Number: 3007740671-2021-00001
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• PMA/PMN Number: K151170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2021
• 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
• Patient Age: 15 YR