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

Model Number	REGULAR PLASTIC APPLICATOR
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer has an allergic reaction to our regular comfort applicator tampon.Allergy was confirmed by allergist with 24 patch test.

• Brand Name: SEVENTH GENERATION
• Common Device Name: REGULAR COMFORT APPLICATOR
• Manufacturer (Section D): ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH; fabrikstra?e 30; d-02692; grosspostwitz, ; GM
• MDR Report Key: 11143862
• Report Number: 1648563-2021-00001
• Device Sequence Number: 3607751
• Product Code: HEB
• UDI-Device Identifier: 00732913451081
• UDI-Public: 00732913451081
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2021
• Report Date (Section F): 01/08/2020

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: Lay User/Patient
• Device Model Number: REGULAR PLASTIC APPLICATOR
• Device Catalogue Number: 45108
• Device Lot Number: 2020036EG 03683/6130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2021
• 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: 64
• Date Report Sent to FDA: 01/08/2020