MAUDE Adverse Event Report: FEMPRO CONSUMER PRODUCTS ULC SEVENTH GENERATION; ULTRA THIN PAD- SUPER LONG

Model Number	67436079
Health Effect - Clinical Code	Rash (2033)
Date of Event	07/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Sonumer used out ultra thin super long pads and experiences a rash in all areas of contact with our products.

• Brand Name: SEVENTH GENERATION
• Common Device Name: ULTRA THIN PAD- SUPER LONG
• Manufacturer (Section D): FEMPRO CONSUMER PRODUCTS ULC; 1330 jean-berchmans0michaud; drummondville, quebec J2C2Z 5; CA J2C2Z5
• MDR Report Key: 12304035
• Report Number: 1648563-2021-00006
• Device Sequence Number: 17061573
• Product Code: HHD
• UDI-Device Identifier: 00732913446827
• UDI-Public: 732913446827
• 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: 67436079
• Device Lot Number: 33 019 02:32:32.
• 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