MAUDE Adverse Event Report: ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH SEVENTH GENERATION INC.; REGULAR PLANT BASED PLASTIC APPLICATOR TAMPON

Model Number	REGULAR PLANT BASED PLASTIC APPLICATOR
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer use seventh generation plant based plastic applicator regular tampon.During insertion consumer had inside plunger piece pull all the way through outer tube and remain in her vagina.She was unable to retrieve herself, and went to the emergency room for assistance after hours.They were able to remove the object without further incident.

• Brand Name: SEVENTH GENERATION INC.
• Common Device Name: REGULAR PLANT BASED PLASTIC APPLICATOR TAMPON
• Manufacturer (Section D): ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH; fabrikstra?e 30; d-02692; grosspostwitz, ; GM
• MDR Report Key: 9969030
• Report Number: 1648563-2020-00001
• Device Sequence Number: 3835901
• Product Code: HEB
• UDI-Device Identifier: 10732913447982
• UDI-Public: 10732913447982
• Combination Product (Y/N): N
• 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): 01/13/2020
• Report Date (Section F): 01/14/2020

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 PLANT BASED PLASTIC APPLICATOR
• Device Lot Number: 04383/5816
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 01/13/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 30 YR
• Patient Weight: 59
• Date Report Sent to FDA: 01/14/2020