MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-12-24 for DYNABLAST PASTE 0.5CC 10.210.1050 manufactured by Keystone Dental.
[4074045]
The clinician contacted keystone dental on (b)(6) 2013 and reported that a pt complained of itchiness and hives all over the body since the dynablast procedure on (b)(6) 2013. The pt has been taking benadryl for the symptoms since (b)(6). According to the incident narrative the site was grafted on (b)(6) 2013, (b)(6) was not reported. The pt was prescribed amoxicillin after the grafting procedure. The pt complained of hives at the one month post op visit, the pt was advised to stop taking amoxicillin. The pt was seen in early (b)(6) and noted that the symptoms did not subside. The pt did not report any allergies at the time of surgery, but did mention a known sensitivity to medical tape.
Patient Sequence No: 1, Text Type: D, B5
[11478833]
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. No add'l complaints from this lot were identified during a review of keystone complaints database. (b)(4) performed a detailed review of the mfg records which included (b)(6), demineralize batch record #12100114, and verified that product was manufactured and released in accordance with the product specs. A review of the sterilization certificate of processing verified that the product was sterilized on (b)(4) 2013, in load 13d13 and was sterilized from dose 28. 2 kgy to 30. 8 kgy. The product was sterilized within specs of min dose 25. 0 kgy to max dose 35. 0 kgy. (b)(4) certifies that the materials listed above (as described by its mfr) received the above doses within the precision and accuracy of the dosimetry system employed. The products are terminally sterilized to a sterility assurance level (sal) of 10-6. Keystone dental investigation did not reveal any mfg or sterilization issues that may contribute to the reported incident. The pt has known sensitivity to medical tape. The root cause of this occurrence could not be determined. Keystone dental reference: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005990499-2013-00010 |
| MDR Report Key | 3556936 |
| Report Source | 05,07 |
| Date Received | 2013-12-24 |
| Date of Report | 2013-12-05 |
| Date of Event | 2013-09-01 |
| Date Mfgr Received | 2013-12-05 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2014-02-05 |
| 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 |
| 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 | 2013-12-24 |
| Model Number | NA |
| Catalog Number | 10.210.1050 |
| Lot Number | 130638 |
| ID Number | NA |
| Device Expiration Date | 2015-04-30 |
| 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 |
| Manufacturer Address | BURLINGTON MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-12-24 |