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

Model Number 67436079

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

Patient Problem Rash (2033)

Event Date 07/11/2021

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 265970565
• Report Number: 1648563-2021-00006
• Device Sequence Number: 1
• Product Code: HHD
• UDI-Device Identifier: 00732913446827
• UDI-Public: 732913446827
• 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: 67436079
• Device Lot Number: 33 019 02:32:32.
• 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