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

Model Number	REGULAR COMFORT APPLICATOR
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Customer indicated she had a difficult time removing tampon because tampon was inserted in the applicator upside down leading to up side down insertion into her body.

• 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: 8746232
• Report Number: 1648563-2019-00008
• Device Sequence Number: 1668566
• 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): 06/28/2019
• Report Date (Section F): 06/28/2019

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 COMFORT APPLICATOR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 06/28/2019
• Initial Date Received by Manufacturer: Not provided
• Initial 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: 06/28/2019