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

Lot Number 1709598

Device Problems Detachment Of Device Component (1104); Unraveled Material (1664)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Consumer stated that tampon components separated at removal, most probably after tampon unravelling.Part of the tampon remained as a consequence of components separation.Removed succesfully by user.No permanent impairement/damage reported.

• Brand Name: LOLA
• Type of Device: UNSCENTED MENSTRUAL TAMPON
• Manufacturer (Section D): TOSAMA D.O.O.; saranoviceva 35, vir; si-1230; domzale, 1230 ; SI 1230
• Manufacturer Contact: janez obreza ; saranoviceva 35; vir, si-1230; domzale, 1230 ; SI 1230
• MDR Report Key: 7276065
• MDR Text Key: 100527345
• Report Number: 3007740671-2018-00002
• Device Sequence Number: 1
• Product Code: HEB
• 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: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 1709598
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2018
• 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