MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-03-18 for AH PLUS ROOT CANAL SEALER 60620112 manufactured by Dentsply Detrey Gmbh.
[5593037]
In this event it was reported that after having a root canal filled with ah plus, a pt experienced an allergic reaction. The symptoms reported were rash on the body, swollen throat, hard to swallow. The pt was treated with betapred arierius and has not yet fully recovered.
Patient Sequence No: 1, Text Type: D, B5
[13104588]
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 dependant upon the severity of the individual allergic response and subsequent exposure of the same material. Therefore, this event meets the criteria for reportability per 21 cfr part 803. The device is available for eval, though has not been returned as of this report. Eval results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010638-2015-00003 |
| MDR Report Key | 4620610 |
| Report Source | 01,05 |
| Date Received | 2015-03-18 |
| Date of Report | 2015-02-19 |
| Date of Event | 2014-10-12 |
| Date Mfgr Received | 2015-02-19 |
| Date Added to Maude | 2015-03-23 |
| 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, SUSQUEHANNA COMMERCE CTR, W |
| Manufacturer City | YORK PR 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 ROOT CANAL SEALER |
| Generic Name | ROOT CANAL FILLING RESIN |
| Product Code | KIF |
| Date Received | 2015-03-18 |
| Catalog Number | 60620112 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY DETREY GMBH |
| Manufacturer Address | KONSTANZ GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-03-18 |