SEA-BOND WAFERS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-27 for SEA-BOND WAFERS manufactured by .

Event Text Entries

[3768589] I used sea bond wafers on my dentures and had heart palpitations. I had to use 4 wafers as my gums and false teeth were hurting me. I want you to put 4 wafers in your mouth and have your pulse taken before and after and you will see your heart rate change. A safe product would not cause this so the wafers contain harmful substances. After seeing these harmful effects i want you to issue an order for sea bond to cease selling a dangerous product; and i want a whistle blowers fee from the billion dollar fine they pay for selling an defective product that is harmful to the body. I personally made the "test" on my own body as noted above. This is a dangerous product. When 4 wafers cause such harmful result; even using one has the same dangerous substance in it. Dates of use: 5 years. Event reappeared after reintroduction: yes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5032069
• MDR Report Key: 3381560
• Date Received: 2013-09-27
• Date of Report: 2013-09-26
• Date of Event: 2013-09-20
• Date Added to Maude: 2013-10-03
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: SEA-BOND WAFERS
• Generic Name: DENTURE ADHESIVE
• Product Code: KXX
• Date Received: 2013-09-27
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0

Device Sequence Number: 2

• Brand Name: SEA-BOND WAFERS
• Generic Name: DENTURE ADHESIVE
• Product Code: KXX
• Date Received: 2013-09-27
• Device Sequence No: 2
• Device Event Key: 0

Device Sequence Number: 3

• Brand Name: SEA-BOND WAFERS
• Generic Name: DENTURE ADHESIVE
• Product Code: KXX
• Date Received: 2013-09-27
• Device Sequence No: 3
• Device Event Key: 0

Device Sequence Number: 4

• Brand Name: SEA-BOND WAFERS
• Generic Name: DENTURE ADHESIVE
• Product Code: KXX
• Date Received: 2013-09-27
• Device Sequence No: 4
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2013-09-27