MAUDE Adverse Event Report: FEMPRO CONSUMER PRODUCTS ULC SEVENTH GENERATION; MAXI PAD- REGULAR

Model Number	67245369
Health Effect - Clinical Code	Rash (2033)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer used our regular maxi tampon.After use she noticed skin irritation only in areas where adhesive came in direct contact with skin after movement of the pad.Consumer discontinued using product and no medical treatment was sought.

• Brand Name: SEVENTH GENERATION
• Common Device Name: MAXI PAD- REGULAR
• Manufacturer (Section D): FEMPRO CONSUMER PRODUCTS ULC; 1330 jean-berchmans0michaud; drummondville, quebec J2C2Z 5; CA J2C2Z5
• MDR Report Key: 12302228
• Report Number: 1648563-2021-00004
• Device Sequence Number: 3807685
• Product Code: HHD
• UDI-Device Identifier: 00732913450008
• UDI-Public: 732913450008
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2021
• Report Date (Section F): 08/10/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 67245369
• Device Lot Number: 20 167 FP7 07:01:32
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 08/10/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2021
• 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: 08/10/2021