MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-12-01 for DYNABLAST PASTE 0.5CC 10.210.1050 manufactured by Keystone Dental Inc.
[5215014]
The clinician reported that a male patient, who has been under his care for 10 years, underwent a tooth extraction procedure for dental site 3. The atraumatic extraction was performed on site 3 and the palatal socket was grafted with dynablast from lot#140018. The patient became flush, experienced heart palpitations and lost consciousness shortly after the graft procedure was completed. The graft was subsequently suctioned and the patient was transported to the emergency room by ambulance.
Patient Sequence No: 1, Text Type: D, B5
[12512081]
This product is contract manufactured for keystone dental by (b)(4). Keystone dental has an exclusive license to sell the dynablast product for dental applications from (b)(4), the developer of the product. This occurrence was communicated to the contract manufacturer (b)(4) and a review of the manufacturing records is underway, a f/u report detailing the manufacturing findings will follow. No additional complaints from this lot were identified during a review of keystone complaints database. This patient has no known allergies. This patient experienced a similar outcome from a previous grafting procedure two months earlier, ref keystone dental medwatch report: 3005990499-2014-00001, keystone dental reference: (b)(4). Polymyxin sulfate b, bacitracin, gentimycin and iodine are used in upstream processing and trace amounts may remain in the final product. Consequently the dynablast ifu lists contraindications for patients with known sensitivities to these processing agents. A copy of the dynablast ifu was forwarded to the clinician. The root cause of this occurrence remains inconclusive at this time. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005990499-2014-00002 |
| MDR Report Key | 4307935 |
| Report Source | 05,06,07 |
| Date Received | 2014-12-01 |
| Date of Report | 2014-12-01 |
| Date of Event | 2014-10-30 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2014-12-10 |
| 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 | LIZ CACCIOLA, VP OPERATIONS |
| Manufacturer Street | 144 MIDDLESEX TURNPIKE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7813283390 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNABLAST PASTE 0.5CC |
| Product Code | NUN |
| Date Received | 2014-12-01 |
| Model Number | NA |
| Catalog Number | 10.210.1050 |
| Lot Number | 14018 |
| ID Number | NA |
| Device Expiration Date | 2016-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KEYSTONE DENTAL INC |
| Manufacturer Address | BURLINGTON MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-12-01 |