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

Model Number	REGULAR
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer indicated extra piece of plastic from applicator lodged in cotton wading.

• Brand Name: SEVENTH GENERATION
• Common Device Name: REGULAR PLASTIC APPLICATOR TAMPON
• Manufacturer (Section D): ONTEX HYGIENEARTIKEL GMBH; fabrikstrasse 30; grosspostwitz sachsen, 96151 00; GM 9615100
• MDR Report Key: 8362907
• Report Number: 1648563-2019-00003
• Device Sequence Number: 1203670
• Product Code: HEB
• UDI-Device Identifier: 00732913451081
• UDI-Public: 00732913451081
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2019
• Report Date (Section F): 02/22/2019

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: REGULAR
• Device Lot Number: 2017340EG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 02/22/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2019
• 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: 64
• Date Report Sent to FDA: 02/22/2019