MAUDE Adverse Event Report: ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH SEVENTH GENERATION; SUPER PLASTIC APPLICATOR TAMPON

Model Number	SUPER
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer was unable to find string when removing tampon.When she was able to remove it she noticed that tampon was inserted into the applicator upside down.

• Brand Name: SEVENTH GENERATION
• Common Device Name: SUPER PLASTIC APPLICATOR TAMPON
• Manufacturer (Section D): ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH; fabrikstra?e 30; d-02692; grosspostwitz, ; GM
• MDR Report Key: 10214770
• Report Number: 1648563-2020-00003
• Device Sequence Number: 11330952
• Product Code: HEB
• UDI-Device Identifier: 10732913447999
• UDI-Public: 10732913447999
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2020
• Report Date (Section F): 06/30/2020

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: SUPER
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 06/30/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 54