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

Model Number	67239580
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A long time user of seventh generation tampons inserted a super comfort applicator tampon.After insertion she noticed there was no string.She struggled to get it out until her husband was eventually able to retrieve it.No medical intervention was required.

• Brand Name: SEVENTH GENERATION
• Common Device Name: SUPER COMFORT APPLICATOR TAMPON
• Manufacturer (Section D): ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH; fabrikstrasse 30; grosspostwitz, D-026 92; GM D-02692
• MDR Report Key: 8569734
• Report Number: 1648563-2019-00004
• Device Sequence Number: 2075727
• 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
• Report Date (Section B): 05/01/2019
• Report Date (Section F): 05/01/2019

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: No Information
• Device Model Number: 67239580
• Device Lot Number: 2018103EG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 05/01/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2019
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 59
• Date Report Sent to FDA: 05/01/2019