MAUDE Adverse Event Report: ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH SEVENTH GENERATION; COMFORT APPLICATOR TAMPONS LIGHT

Model Number	67668400
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported that the string came off of the tampons when she used the product.

• Brand Name: SEVENTH GENERATION
• Common Device Name: COMFORT APPLICATOR TAMPONS LIGHT
• Manufacturer (Section D): ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH; fabrikstrasse 30; grosspostwitz, saxony 02692 ; GM 02692
• MDR Report Key: 16065172
• Report Number: 1648563-2022-00006
• Device Sequence Number: 2033516
• Product Code: HEB
• UDI-Device Identifier: 00732913447824
• UDI-Public: 00732913447824
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2022
• Report Date (Section F): 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 67668400
• Device Lot Number: 18582/6297
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/04/2022
• Event Location: Home
• Date Report to Manufacturer: 12/22/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown