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

Model Number	SUPER PLASTIC APPLICATOR
Health Effect - Clinical Codes	Irritation (1941); Discomfort (2330)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer tried our tampon and indicated they were dry and uncomfortable.She indicated they caused irritation where she reached out to her obgyn who recommended discontinuing use.
Event or Problem Description
Customer tried our tampon and indicated they were dry and uncomrtable.She indicated they caused irritation where wher reached out to her obgyn who recommended disconinuted use.

• Brand Name: SEVENTH GENERATION
• Common Device Name: MENSTRUAL TAMPON- SUPER PLASTIC APPLICATOR
• Manufacturer (Section D): ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH; fabrikstra[?]e 30; d-02692; grosspostwitz, ; GM
• MDR Report Key: 8736900
• Report Number: 1648563-2019-00005
• Device Sequence Number: 13850766
• Product Code: HEB
• UDI-Device Identifier: 10732913447999
• UDI-Public: 10732913447999
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2019
• Report Date (Section F): 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: SUPER PLASTIC APPLICATOR
• Device Catalogue Number: AY000013-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 06/27/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 59
• Date Report Sent to FDA: 06/27/2019