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

Model Number	SUPER COMFORT APPLICATOR
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Customer indicated inserted a tampon that was inverted inside of the applicator.This made removal difficult.
Event or Problem Description
Customer indicated inserted a tampon that was inverted inside of the applicator.This made removal difficult.

• Brand Name: SEVENTH GENERATION
• Common Device Name: SUPER COMFORT APPLICATOR TAMPON
• Manufacturer (Section D): ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH; fabrikstra[?]e 30; d-02692; grosspostwitz, ; GM
• MDR Report Key: 8746169
• Report Number: 1648563-2019-00007
• Device Sequence Number: 11185094
• Product Code: HEB
• UDI-Device Identifier: 00732913451098
• UDI-Public: 00732913451098
• 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,Followup
• 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: SUPER COMFORT APPLICATOR
• Device Lot Number: 23681/5645
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 06/28/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 01/13/2020
• 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