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..
[20326464]
The clinician reported that a male patient, who has been under his care for 10 years, underwent a tooth extraction procedure for dental site 30. After the atraumatic extraction was completed on site 30, the site was grafted with dynablast from lot # 140018 and the site was covered with gelfoam and sutured. The patient then became flush and experienced heart palpitations, at which time he was closely monitored. The patient went to the restroom and when he did not return in a timely manner, the staff followed up to find the patient unconscious on the floor. The staff initiated a 911 call and the patient was transported to the emergency room by ambulance. The patient was treated and released and the graft remained in place. The clinician followed up with the patient via telephone and was told by the patient that he had consulted with his primary care person and that they suspected he had a reaction to the novocaine and prescribed him an epipen. The primary care office recommended that the patient return to the original clinician for a small dose of novocaine to either confirm or rule it out as the source of the incident. The patient received a small dose of novocaine without any side effects.
Patient Sequence No: 1, Text Type: D, B5
[20506149]
(b)(4). This occurrence was communicated to the contract manufacturer (b)(4) and a review of the manufacturing records is underway, a follow-up report detailing the manufacturing findings will follow. No additional complaints from this list were identified during a review of keystone complaints database. This patient has no known allergies. 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 | 3005990499-2014-00001 |
| MDR Report Key | 4308546 |
| Report Source | 05,06,07 |
| Date Received | 2014-12-01 |
| Date of Report | 2014-12-01 |
| Date of Event | 2014-08-28 |
| 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 |
| 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 |
| Catalog Number | 10.210.1050 |
| Lot Number | 140871 |
| Device Expiration Date | 2016-06-30 |
| 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 |