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

Model Number	REGULAR- PLASTIC APPLICATOR TAMPON
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During insertion, plastic applicator plunger pushed all the way through tampon housing into consumers body.This happened on both attempts.

• Brand Name: SEVENTH GENERATION
• Common Device Name: PLASTIC COMFORT APPLICATOR TAMPON
• Manufacturer (Section D): ONTEX HYGIENEARTIKEL GMBH; fabrikstrasse 30; grosspostwitz sachsen, 96151 00; GM 9615100
• MDR Report Key: 8044941
• Report Number: 1648563-2018-00010
• Device Sequence Number: 13778601
• Product Code: HEB
• UDI-Device Identifier: 10732913447982
• UDI-Public: 10732913447982
• 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): 11/05/2018
• Report Date (Section F): 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: REGULAR- PLASTIC APPLICATOR TAMPON
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 11/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2018
• 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: Required Intervention
• Patient Age: 30 YR
• Patient Weight: 59