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

Model Number	67239378
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported that the individual wrapper of one of the tampons in the box was not fully sealed although the box was in perfect condition.Consumer did not use the tampon.

• Brand Name: SEVENTH GENERATION
• Common Device Name: COMFORT APPLICATOR TAMPONS REGULAR
• Manufacturer (Section D): ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH; fabrikstrasse 30; grosspostwitz, saxony 02692 ; GM 02692
• MDR Report Key: 18112017
• Report Number: 1648563-2023-00003
• Device Sequence Number: 12680346
• Product Code: HEB
• UDI-Device Identifier: 00732913451081
• UDI-Public: 00732913451081
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/10/2023
• Report Date (Section F): 11/10/2023

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: 67239378
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/06/2023
• Event Location: Home
• Date Report to Manufacturer: 11/10/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown