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

Model Number	67239378
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported that 2 out of the first 8 tampons out of a box of 18 the withdrawal string was missing and tampon could not be used.

• 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: 17798227
• Report Number: 1648563-2023-00002
• Device Sequence Number: 14893414
• 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): 09/21/2023
• Report Date (Section F): 09/22/2023

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: 2022051EG - 05183/6658
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/25/2023
• Event Location: Home
• Date Report to Manufacturer: 09/22/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown