MAUDE Adverse Event Report: ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH SEVENTH GENERATION; SUPER PLASTIC APPLICATOR TRAMPON

Model Number	AY000013-01 V5
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Foriegn metal object found in tampon when customer removed after use.No injury sustained.

• Brand Name: SEVENTH GENERATION
• Common Device Name: SUPER PLASTIC APPLICATOR TRAMPON
• Manufacturer (Section D): ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH; fabrikstrae 30; grosspostwitz, D-026 92; GM D-02692
• MDR Report Key: 11573055
• Report Number: 1648563-2021-00003
• Device Sequence Number: 3086238
• Product Code: HEB
• UDI-Device Identifier: 10732913447999
• UDI-Public: 10732913447999
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2021
• Report Date (Section F): 03/17/2021

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: AY000013-01 V5
• Device Lot Number: 17184/6279 19:32
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2021
• 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
• Date Report Sent to FDA: 03/17/2021