MAUDE Adverse Event Report: SEVENTH GENERATION SEVENTH GENERATION; UNSCENTED MENSTRUAL TAMPON WITH APPLICATOR

Model Number APPLICATOR TAMPON

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/08/2017

Event Type  Injury  

Event Description

Consumer was using the plastic applicator tampon when the skinny portion of the applicator came apart and stayed inside her vagina.The consumer was able to pull the piece of applicator out but was concerned it happened so easily.Consumer used the remainder of the box of tampons and had no issues.

• Brand Name: SEVENTH GENERATION
• Type of Device: UNSCENTED MENSTRUAL TAMPON WITH APPLICATOR
• Manufacturer (Section D): SEVENTH GENERATION; 60 lake street; suite 3n; burlington VT 05401
• MDR Report Key: 7213857
• MDR Text Key: 98043690
• Report Number: 1648563-2018-00001
• Device Sequence Number: 1
• Product Code: HEB
• UDI-Device Identifier: 00732913451081
• UDI-Public: 00732913451081
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: APPLICATOR TAMPON
• Device Lot Number: (10)13982/5319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/04/2017
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 01/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 57