MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-03-27 for DENTAURUM TIES DENT-2SIL manufactured by Dentsply Raintree Essix Glenroe.
[20655806]
In this event it was reported that after the use of elastic ligature ties, a pt had an allergic reaction. Further details of the symptoms and event are not available.
Patient Sequence No: 1, Text Type: D, B5
[20870749]
While it is unk if the device used in this case caused or contributed to the pt's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material. Reportability per 21 cfr part 803. The device was not returned for eval and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009683512-2014-00001 |
| MDR Report Key | 3732979 |
| Report Source | 01,08 |
| Date Received | 2014-03-27 |
| Date of Report | 2014-02-26 |
| Date Mfgr Received | 2014-02-26 |
| Date Added to Maude | 2014-04-09 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W PHILADELPHIA ST STE 60 |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DENTAURUM TIES |
| Generic Name | BAND, ELASTIC, ORTHODONTIC |
| Product Code | ECI |
| Date Received | 2014-03-27 |
| Catalog Number | DENT-2SIL |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY RAINTREE ESSIX GLENROE |
| Manufacturer Address | SARASOTA FL 34243 US 34243 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-27 |