MAUDE Adverse Event Report: ONTEX HYGIENEARTIKEL GMBH SEVENTH GENERATION; REGULAR PLASTIC APPLICATOR TAMPON

Model Number REGULAR

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/16/2019

Event Type  malfunction  

Event Description

Consumer indicated extra piece of plastic from applicator lodged in cotton wading.

• Brand Name: SEVENTH GENERATION
• Type of Device: REGULAR PLASTIC APPLICATOR TAMPON
• Manufacturer (Section D): ONTEX HYGIENEARTIKEL GMBH; fabrikstrasse 30; grosspostwitz sachsen, 96151 00; GM 9615100
• MDR Report Key: 8362907
• MDR Text Key: 137384729
• Report Number: 1648563-2019-00003
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: REGULAR
• Device Lot Number: 2017340EG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2019
• Event Location: Home
• Date Report to Manufacturer: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 64