MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-12-21 for ULTRACAL XS UNKNOWN manufactured by Ultradent Products, Inc..
[95587799]
On november 29, 2016 (one day before the oral surgeon filed medwatch report no. Mw5066469 with the fda), ultradent's customer service manager received a telephone call from an oral surgeon (dr. (b)(6)). During the call, dr. (b)(6) explained that he was currently treating a patient who had an endodontic procedure performed by another dentist approximately 6 weeks before. Dr. (b)(6) further claimed that, as a result of the procedure, the patient was experiencing pain and paresthesia in her jaw, a burning sensation in her lips, and that several of the patient's teeth had become loose. Dr. (b)(6) admitted that he did not know the name of any particular ultradent product, but mentioned the use of a root canal sealer and then continually referenced calcium hydroxide. On the same day that he called ultradent customer service, dr. (b)(6) also spoke to 2 ultradent-employed dentists. During each of those conversations, dr. (b)(6) continually referenced calcium hydroxide, but did not identify any particular ultradent product. Furthermore, in each of these conversations, dr. (b)(6) was asked to provide the name and contact information of the dentist that performed the initial procedure so that ultradent could gather as much information about the alleged product and injury as possible. However, dr. (b)(6) repeatedly refused to provide that information to ultradent. Accordingly, ultradent has not been able to communicate with the dentist and determine, among other things, whether or not the product at issue is actually an ultradent product. One day after calling ultradent, and despite failing to identify any specific ultradent product during those conversations, dr. (b)(6) filed a medwatch report with the fda, wherein, for the first time, he identifies the product used in the procedure as "ultracal (ca(oh)2). " because dr. (b)(6) has refused to provide ultradent with the contact information of the dentist that performed the initial procedure, ultradent has very limited knowledge of the facts and circumstances surrounding the alleged injury, including whether an ultradent product was even involved. However, based on the information that is available, it appears that the patient's injury was caused by the dentist's gross misuse of a product containing calcium hydroxide. The dentist seems to have injected a very large amount of calcium hydroxide beyond the apex of the patient's tooth. Importantly, dr. (b)(6) does not identify the amount of calcium hydroxide used, nor does he claim, either during the telephone calls with ultradent or in the medwatch report, that the alleged ultradent product was defective, faulty, or otherwise malfunctioned in any way.
Patient Sequence No: 1, Text Type: N, H10
[95587801]
On january 4, 2017, ultradent received a letter from the fda dated (b)(6) 2016 regarding a medwatch report submitted by an oral surgeon. In the medwatch report, the oral surgeon states that he began seeing a patient 6 weeks after the patient's dentist injected the product ultracal xs into the patient's lower incisor tooth (the oral surgeon does not identify the quantity of ultracal xs injected). The oral surgeon claims that the medicament embolized into vessels around the patient's tooth, causing chin pain, numbness, and loosening of at least 7 teeth. The oral surgeon further claims that the product ifu does not provide instructions for treating this problem or a warning about this type of complication. The oral surgeon does not claim that the ultracal xs product was defective, faulty, or otherwise malfunctioned in any way.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718912-2017-00043 |
| MDR Report Key | 7139676 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-12-21 |
| Date of Report | 2017-12-21 |
| Date of Event | 2016-10-27 |
| Date Mfgr Received | 2017-01-04 |
| Date Added to Maude | 2017-12-21 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. RONA MURPHY |
| Manufacturer Street | 505 WEST 10200 SOUTH |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8015534200 |
| Manufacturer G1 | ULTRADENT PRODUCTS, INC. |
| Manufacturer Street | 505 WEST 10200 SOUTH |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84095 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRACAL XS |
| Generic Name | CALICIUM HYDROXIDE |
| Product Code | EJK |
| Date Received | 2017-12-21 |
| Model Number | NA |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTRADENT PRODUCTS, INC. |
| Manufacturer Address | 505 WEST 10200 SOUTH SOUTH JORDAN UT 84095 US 84095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-21 |