MAUDE Adverse Event Report: GLAXOSMITHKLINE CONSUMER HEALTHCARE LP SUPER POLIGRIP ZINC FREE DENTURE AND PARTIALS ADHESIVE CREAM, 2.4 OUNC; CARBOXYMETHYLCELLULOSE SODIUM OR POLYVINYL METHYLETHER MALEIC ACID CALCIUM-SODIU

Device Problem Nonstandard Device (1420)

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

Event Date 10/06/2022

Event Type  malfunction  

Event Description

Ordered 4 boxes and received an email about the recall.Did not open and could not use.Wasted money.

• Brand Name: SUPER POLIGRIP ZINC FREE DENTURE AND PARTIALS ADHESIVE CREAM, 2.4 OUNC
• Type of Device: CARBOXYMETHYLCELLULOSE SODIUM OR POLYVINYL METHYLETHER MALEIC ACID CALCIUM-SODIU
• Manufacturer (Section D): GLAXOSMITHKLINE CONSUMER HEALTHCARE LP
• MDR Report Key: 15977581
• MDR Text Key: 305586253
• Report Number: MW5113767
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/10/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2022
• Patient Sequence Number: 1
• Patient Sex: Female