MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-03-04 for SEA-BOND DENTURE ADHESIVE UPPER WAFERS manufactured by Combe Incorporated.
[1288185]
Initial reporter stated that she believes that her difficulty breathing and subsequent admittance to the hospital from (b) (6) 2010 through (b) (6) 2010, was a result of her use of sea bond denture adhesive. She said she experienced a similar episode in (b) (6) 2009 and was admitted to the hospital for 1 day. She said the hospital diagnosed her with allergy, bronchitis or asthma attack. She was treated with a breathing machine every 4 hours while in the hospital. Was given a breathing machine to use at home, but has not used it. She sated that she has used sea bond on her upper denture since (b) (6) 2009, applies it daily and sleeps with her denture in her mouth. She used sea bond this way during her hospital stay as well. She said she saw her primary care physician (b) (6) 2010 and he told her she had a reaction to sea bond. She said he advised her to stop using sea bond and prescribed singulair. She said she has not experienced breathing problems since then.
Patient Sequence No: 1, Text Type: D, B5
[8516486]
Have not received medical records substantiating the reported breathing difficulty was caused by sea bond. Results of evaluation of retained sample of lot r09l010 show no issues that suggest any defects associated with the lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1450238-2010-00001 |
| MDR Report Key | 1624484 |
| Report Source | 04 |
| Date Received | 2010-03-04 |
| Date of Report | 2010-02-12 |
| Date of Event | 2010-02-02 |
| Date Mfgr Received | 2010-02-12 |
| Device Manufacturer Date | 2009-11-01 |
| Date Added to Maude | 2010-03-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1101 WESTCHESTER AVE. |
| Manufacturer City | WHITE PLAINS NY 10604 |
| Manufacturer Country | US |
| Manufacturer Postal | 10604 |
| Manufacturer Phone | 9144614481 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEA-BOND DENTURE ADHESIVE UPPER WAFERS |
| Product Code | KXW |
| Date Received | 2010-03-04 |
| Lot Number | R09L010 |
| ID Number | 1150900205 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COMBE INCORPORATED |
| Manufacturer Address | WHITE PLAINS NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2010-03-04 |