MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-07-06 for SEA BOND DENTURE ADHESIVE LOWER WAFERS manufactured by Combe Laboratories.
[2818618]
Initial reporter stated that he believes that his difficulty breathing and subsequent admittance to the hospital was a result of his use of (b)(4) denture adhesive. In error, this case was not immediately brought to the attention of the manager of product integrity by the consumer resources agent who received the call on (b)(4) 2012. On (b)(6) 2012, combe incorporated received a letter from initial reporter stating that he used (b)(4) which made his mouth sticky, making it difficult to swallow and breathe. He requested a refund of purchase price. On (b)(6) 2012, the initial reporter called combe to inquire about refund. The consumer resources agent asked if he required medical attention for his experience and he replied that he had been in the (b)(6) hospital and was released on (b)(6) 2012. He said he thinks that he inhaled some of the adhesive. He said he is doing well now. Agent reminded him to return the unused wafers. Manager of product integrity at combe observed the returned wafers on (b)(4) 2012, replayed the (b)(4) 2012 call and noted the reported hospitalization. Called consumer on (b)(4) 2012 and sent letter requesting further info. He has not responded.
Patient Sequence No: 1, Text Type: D, B5
[10023081]
Qc will evaluate returned product sample upon receipt from combe white plains. Will report qc eval results to fda when complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1450238-2012-00001 |
| MDR Report Key | 2655608 |
| Report Source | 04 |
| Date Received | 2012-07-06 |
| Date of Report | 2012-07-03 |
| Date of Event | 2012-04-28 |
| Date Mfgr Received | 2012-04-30 |
| Device Manufacturer Date | 2012-01-01 |
| Date Added to Maude | 2012-07-17 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1101 WESTCHESTER AVENUE |
| 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 LOWER WAFERS |
| Product Code | KXW |
| Date Received | 2012-07-06 |
| Returned To Mfg | 2012-05-11 |
| Lot Number | R12A065 |
| ID Number | 1150906508 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COMBE LABORATORIES |
| Manufacturer Address | WHITE PLAINS NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-07-06 |