MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-16 for DYNABLAST PASTE 0.5CC 10.210.1050 manufactured by Keystone Dental Inc.
[64903904]
Graft remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[64903905]
This clinician contacted keystone dental on (b)(6) 2016 to report that a patient receiving dyanblast paste following an immediate extraction and grafting procedure 2 weeks ago had complained of pain, numbness, and swelling at the grafting site. According to the incident narrative, the tooth at fdi-iso dental site 33, was extracted on (b)(6) 2016 and immediately grafted with dynablast paste. On (b)(6) 2016, the patient reported regaining feeling at the grafting site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005990499-2016-00007 |
| MDR Report Key | 6254154 |
| Date Received | 2017-01-16 |
| Date of Report | 2016-01-10 |
| Date of Event | 2016-12-05 |
| Date Mfgr Received | 2017-12-15 |
| Device Manufacturer Date | 2016-04-11 |
| Date Added to Maude | 2017-01-16 |
| 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 | DENTAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOSH HARKESS |
| Manufacturer Street | 154 MIDDLESEX TURNPIKE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7813283526 |
| Manufacturer G1 | KEYSTONE DENTAL INC |
| Manufacturer Street | 154 MIDDLESEX TPK |
| Manufacturer City | BURLINGTON MA 018034403 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 018034403 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DYNABLAST PASTE 0.5CC |
| Generic Name | DYNABLAST PASTE 0.5CC |
| Product Code | NUN |
| Date Received | 2017-01-16 |
| Model Number | NA |
| Catalog Number | 10.210.1050 |
| Lot Number | 155744 |
| Device Expiration Date | 2018-02-28 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KEYSTONE DENTAL INC |
| Manufacturer Address | 154 MIDDLESEX TPK BURLINGTON MA 018034403 US 018034403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-01-16 |