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

Model Number	68525785
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer found foreign object in menstrual pad.

• Brand Name: SEVENTH GENERATION
• Common Device Name: MAXI PAD, REGULAR
• Manufacturer (Section D): FEMPRO CONSUMER PRODUCTS ULC; 1330; rue jean berchmans-michaud; drummondville, quebec J2C2Z 5; CA J2C2Z5
• MDR Report Key: 13233737
• Report Number: 1648563-2022-00001
• Device Sequence Number: 11837126
• Product Code: HHD
• UDI-Device Identifier: 00732913450008
• UDI-Public: 732913450008
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/11/2022
• Report Date (Section F): 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 68525785
• Device Lot Number: 01131FP06 12:52:47
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/29/2021
• Event Location: Home
• Date Report to Manufacturer: 01/11/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/11/2022