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

Lot Number NONE PROVIDED

Device Problems Detachment Of Device Component (1104); Device Contamination with Chemical or Other Material (2944); Protective Measures Problem (3015)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/07/2017

Event Type  Injury  

Event Description

Consumer stated: "i've switched to organic cotton tampons and i like the fact that they are better for my health.What i've noticed is that the cotton sometimes stays inside of me if i took it out when the cotton is dry.Do your tampons have some protective barrier so i don't have to worry about the cotton inside of me and potential health hazards?.

• Brand Name: SEVENTH GENERATION
• Type of Device: UNSCENTED MENSTRUAL TAMPON
• Manufacturer (Section D): SEVENTH GENERATION; 60 lake street; suite 3n; burlington VT 05401
• MDR Report Key: 7214004
• MDR Text Key: 98051874
• Report Number: 1648563-2018-00002
• Device Sequence Number: 1
• Product Code: HEB
• 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: 12/07/2017

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: Other
• Device Lot Number: NONE PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/07/2017
• Device Age: 0 MO
• Event Location: Home
• 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: 25 YR
• Patient Weight: 57