MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-07-09 for AH-26 ROOT CANAL FILLING MATERIAL 60621101 manufactured by Dentsply Detrey Gmbh.
[49125108]
Since this event resulted in medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the malfunction would be likely to cause or contribute to a serious injury should it recur. As such, this event meets the definition of a reportable event per 21 cfr part 803. The device was not available for evaluation. Retain product was tested and found to be within specification.
Patient Sequence No: 1, Text Type: N, H10
[49125109]
It was reported that a doctor overfilled a root canal with ah-26 root canal filling material. The patient experienced paresthesia from their lip to the chin. The doctor revised the root canal filling to alleviate the patient's symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010638-2016-00004 |
| MDR Report Key | 5781042 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-07-09 |
| Date of Report | 2016-06-10 |
| Date of Event | 2016-06-10 |
| Date Mfgr Received | 2016-06-10 |
| Date Added to Maude | 2016-07-09 |
| 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 | 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 | DENTSPLY DETREY GMBH |
| Manufacturer Street | DETREY STRASSE 1 |
| Manufacturer City | KONSTANZ, 78467 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78467 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AH-26 ROOT CANAL FILLING MATERIAL |
| Generic Name | RESIN, ROOT CANAL FILLING |
| Product Code | KIF |
| Date Received | 2016-07-09 |
| Model Number | NA |
| Catalog Number | 60621101 |
| Lot Number | 1211000856 |
| Device Expiration Date | 2017-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY DETREY GMBH |
| Manufacturer Address | DETREY STRASSE 1 KONSTANZ, 78467 GM 78467 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-09 |