MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-03 for BIOPURE MTAD ROOT CANAL CLEANSER BP48R manufactured by Dentsply Tulsa Dental Specialties.
[47747266]
The symptoms described in this event are consistent with other events where dental material was extruded beyond the apex. There has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21cfr part 803. The device is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[47747267]
It was reported that a patient experienced an adverse reaction after the use of biopure mtad. The patient had some swelling on the outside of the jaw and was seen by an oral surgeon post-op and the surgeon said the tooth is fine and doesn't need to be extracted. The doctor stated that during a follow-up that the swelling was going down, but the patient does have some numbness.
Patient Sequence No: 1, Text Type: D, B5
[54582394]
The device was evaluated and found to be within specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2320721-2016-00018 |
| MDR Report Key | 5698658 |
| Date Received | 2016-06-03 |
| Date of Report | 2016-05-06 |
| Date of Event | 2016-05-06 |
| Date Mfgr Received | 2016-07-15 |
| Date Added to Maude | 2016-06-03 |
| 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 TULSA DENTAL SPECIALTIES |
| Manufacturer Street | 608 ROLLING HILLS DRIVE |
| Manufacturer City | JOHNSON CITY TN 37604 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOPURE MTAD ROOT CANAL CLEANSER |
| Generic Name | CLEANSER, ROOT CANAL |
| Product Code | KJJ |
| Date Received | 2016-06-03 |
| Returned To Mfg | 2016-05-27 |
| Model Number | NA |
| Catalog Number | BP48R |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY TULSA DENTAL SPECIALTIES |
| Manufacturer Address | 608 ROLLING HILLS DRIVE JOHNSON CITY TN 37604 US 37604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-03 |