MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-08 for HAWLEY RETAINER 44-500-95 manufactured by Raintree Essix Inc..
[42410499]
While it is unknown if the device used in this case caused or contributed to the patient'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. Therefore, this event meets the criteria for reportability per 21 cfr part 803. At this time, we are unsure if the device will be returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[42410500]
It was reported that a patient experienced an allergic reaction to his hawley retainer. While wearing the retainer, the patient suffers from headaches and his upper palate is itchy. When he removes the retainer, the headaches and itchiness stop.
Patient Sequence No: 1, Text Type: D, B5
[45374983]
The device was not returned for evaluation. A dhr review was conducted with no discrepancies noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036212-2016-00002 |
| MDR Report Key | 5565146 |
| Date Received | 2016-04-08 |
| Date of Report | 2016-03-10 |
| Date Mfgr Received | 2016-04-21 |
| Date Added to Maude | 2016-04-08 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494229 |
| Manufacturer G1 | RAINTREE ESSIX INC. |
| Manufacturer Street | 7290 26TH COURT EAST |
| Manufacturer City | SARASOTA FL 34243 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34243 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAWLEY RETAINER |
| Generic Name | RETAINER, SCREW EXPANSION, ORTHODONTIC |
| Product Code | DYJ |
| Date Received | 2016-04-08 |
| Model Number | NA |
| Catalog Number | 44-500-95 |
| Lot Number | 626842 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RAINTREE ESSIX INC. |
| Manufacturer Address | 7290 26TH COURT EAST SARASOTA FL 34243 US 34243 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-08 |