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

Model Number 68525784

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2021

Event Type  malfunction  

Event Description

Consumer found foreign object in menstrual pad.

• Brand Name: SEVENTH GENERATION
• Type of Device: MAXI PAD, OVERNIGHT
• Manufacturer (Section D): FEMPRO CONSUMER PRODUCTS ULC; 1330; rue jean-berchmans-michaud; drummondville, quebec J2C2Z 5; CA J2C2Z5
• MDR Report Key: 13233794
• MDR Text Key: 285928508
• Report Number: 1648563-2022-00002
• Device Sequence Number: 1
• Product Code: HHD
• UDI-Device Identifier: 00732913450015
• UDI-Public: 732913450015
• 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: 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
• Device Operator: Lay User/Patient
• Device Model Number: 68525784
• Device Lot Number: 05251FP06 10:54:50
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2022
• Distributor Facility Aware Date: 12/27/2021
• Event Location: Home
• Date Report to Manufacturer: 01/11/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1