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

Model Number	SUPER
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Plunger from applicator remained in body after insertion.Super and regular types.Super: (b)(4).Regular: (b)(4).

• Brand Name: SEVENTH GENERATION
• Common Device Name: SUPER COMFORT APPLICATOR TAMPON
• Manufacturer (Section D): ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH; fabrikstra?e 30; d-02692; grosspostwitz, ; GM
• MDR Report Key: 8949855
• Report Number: 1648563-2019-00012
• Device Sequence Number: 13963479
• 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): 08/28/2019
• Report Date (Section F): 08/29/2019

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 Model Number: SUPER
• Device Lot Number: 2019133EG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2019
• 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: 08/29/2019