MAUDE Adverse Event Report: ONTEX HYGIENEARTIKEL GMBH SEVENTH GENERATION; SUPER NON-APPLICATOR TAMPON

Lot Number	2018009EG
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Customer has indicated that our tampon seems more flimsy than normal.They indicated that upon removal the tampon almost feel apart.

• Brand Name: SEVENTH GENERATION
• Common Device Name: SUPER NON-APPLICATOR TAMPON
• Manufacturer (Section D): ONTEX HYGIENEARTIKEL GMBH; fabrikstrasse 30; grosspostwitz sachsen, 96151 00; GM 9615100
• MDR Report Key: 8271945
• Report Number: 1648563-2019-00002
• Device Sequence Number: 1556812
• Product Code: HEB
• UDI-Device Identifier: 00732913451012
• UDI-Public: 00732913451012
• 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): 01/22/2019
• Report Date (Section F): 01/23/2019

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 Lot Number: 2018009EG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2019
• 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: 01/23/2019