MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-05-01 for AH PLUS JET 60620115 manufactured by Dentsply Detrey-dedent.
[5769869]
In this event it was reported that a patient experienced an allergic reaction after treatment with ah plus jet. The symptoms reported included swelling, rash and pain. The patient was treated with cortisone to combat the symptoms.
Patient Sequence No: 1, Text Type: D, B5
[13262149]
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. The device was evaluated and found to be within specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010638-2015-00004 |
| MDR Report Key | 4746077 |
| Report Source | 01,05 |
| Date Received | 2015-05-01 |
| Date of Report | 2015-04-02 |
| Date Mfgr Received | 2015-04-02 |
| Date Added to Maude | 2015-05-05 |
| 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 | 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 | AH PLUS JET |
| Generic Name | ROOT CANAL FILLING RESIN |
| Product Code | KIF |
| Date Received | 2015-05-01 |
| Returned To Mfg | 2015-04-13 |
| Catalog Number | 60620115 |
| Lot Number | 14060000459 |
| Device Expiration Date | 2016-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY DETREY-DEDENT |
| Manufacturer Address | KONSTANZ GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-05-01 |