MAUDE Adverse Event Report: G C AMERICA COE-SOFT DENTURE RELINE MATERIAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Swelling (2091); Swollen Lymph Nodes (2093); Burning Sensation (2146); Reaction (2414); Sensitivity of Teeth (2427); Fluid Discharge (2686)

Event Date 09/15/2016

Event Type  Injury  

Event Description

After the procedure on (b)(6) 2016, reporter stated that her mouth began to sting a lot.The dentist had however informed her of some pain after the procedure.When she got home, she took the dentures out and ate.Her mouth still hurt while she ate.After eating, she put it back on and decided not to use salt water to rinse her mouth due the pain she felt.Gradually, her tongue began to swell and sting.It's the next day she realized she was having an allergic reaction.Her lips got sore, mouth red, then turned to a blistery rash around her mouth and her head felt as if on fire.She called the dentist but got no feedback from him.Reporter stated that she has been hoping these symptoms will subside but to no avail.A couple of days later, her sinuses were stinging and there was a lot of loose, clear drainage which still oozes out till this moment.Reporter stated that her face is getting better but her lymph nodes, upper lip, and front gums are still swollen and sore and it hurts to speak.Reporter is unhappy that she was not aware of what was put in her mouth as far as the ingredients that make up the material are concerned.She is concerned that the manufacturer still wouldn't release that information to her.

• Brand Name: COE-SOFT DENTURE RELINE MATERIAL
• Type of Device: COE-SOFT DENTURE RELINE MATERIAL
• Manufacturer (Section D): G C AMERICA
• MDR Report Key: 6039516
• MDR Text Key: 57982388
• Report Number: MW5065490
• Device Sequence Number: 1
• Product Code: EBI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 57