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

Model Number 67245369

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rash (2033)

Event Date 01/05/2021

Event Type  Injury  

Event 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
• Type of Device: MAXI PAD- REGULAR
• Manufacturer (Section D): FEMPRO CONSUMER PRODUCTS ULC; 1330 jean-berchmans0michaud; drummondville, quebec J2C2Z 5; CA J2C2Z5
• MDR Report Key: 12302228
• MDR Text Key: 265870470
• Report Number: 1648563-2021-00004
• Device Sequence Number: 1
• Product Code: HHD
• UDI-Device Identifier: 00732913450008
• UDI-Public: 732913450008
• 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: 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
• Device Operator: Lay User/Patient
• Device Model Number: 67245369
• Device Lot Number: 20 167 FP7 07:01:32
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2021
• Event Location: Home
• Date Report to Manufacturer: 08/10/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2021
• 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: 59