MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2007-08-03 for FIX TRAY ADHESIVE 61601004 manufactured by Dentsply Detrey-dedent.
[685864]
It was reported that a patient received burns on the mouth and lips after a procedure was performed using affinis silicone impression material secured to the tray using fix tray adhesive; the patient was administered an antibiotic and mouth rinse as a result.
Patient Sequence No: 1, Text Type: D, B5
[7858201]
The directions for use warn that the material is irritating to the eyes, mucosa, and skin and also that allergic reactions may result in susceptible individuals. While allergic reactions to dental materials are known and reported, with medical consequences being depending upon the severity of the individual allergic response and subsequent exposure to the same material, the symptoms reported in this case appear to be more consistent with irritation/burning resulting from contact with the skin/mucosa, rather than a sensitization reaction. The directions for use also indicate that the tray adhesive should be used with alginate impression materials only; the adhesive was used with a silicone material int his event. However, since an antibiotic was administered in this case, the device was returned for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010638-2007-00139 |
| MDR Report Key | 888935 |
| Report Source | 01,05,07 |
| Date Received | 2007-08-03 |
| Date of Report | 2007-07-12 |
| Date Mfgr Received | 2007-07-12 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2007-08-09 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | SUSQUEHANNA COMMERCE CENTER W. 221 W. PHILA. ST., STE 60 |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY DETREY-DEDENT |
| Manufacturer Street | DETREY STRASSE 1 |
| Manufacturer City | KONSTANZ D-78467 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-78467 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIX TRAY ADHESIVE |
| Product Code | EBH |
| Date Received | 2007-08-03 |
| Returned To Mfg | 2007-07-24 |
| Model Number | NA |
| Catalog Number | 61601004 |
| Lot Number | 0605002849 |
| ID Number | NA |
| Device Expiration Date | 2009-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 868308 |
| Manufacturer | DENTSPLY DETREY-DEDENT |
| Manufacturer Address | KONSTANZ GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-08-03 |