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

Lot Number 1713410

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/08/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Consumer stated that tampon string came off while wearing it.The whole tampon stayed in other than the string.No injury was reported, no medical intervention needed.

• 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: 7604953
• MDR Text Key: 111350221
• Report Number: 3007740671-2018-00016
• 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: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 1713410
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2018
• 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