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

Model Number	SUPER COMFORT
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer used tampon and removed before bed.When customer woke up in the morning to use the bathroom some kind of material fell out of vagina into toilet.Customer thinks it may be part of tampon, but noticed not irregularities in the tampon prior to use.

• Brand Name: SEVENTH GENERATION INC
• Common Device Name: SUPER COMFORT APPLICATOR
• Manufacturer (Section D): ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH; fabrikstra?e 30; d-02692; grosspostwitz, ; GM
• MDR Report Key: 8949807
• Report Number: 1648563-2019-00011
• Device Sequence Number: 2471592
• 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): 08/27/2019
• Report Date (Section F): 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: SUPER COMFORT
• Device Lot Number: 02381/5533
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 08/28/2019
• 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: 08/28/2019