MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-08-21 for LYNAL TISSUE CONDITIONER AND TEMPORARY RELINER 653006 manufactured by Dentsply Caulk.
[23749564]
While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material. Therefore, this event meets the criteria for reportability per 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
[23749565]
In this event it was reported that on (b)(6) 2015 a dentist used lynal to reline a denture for a male patient. On (b)(6) 2015 the patient contacted the dentist stating that he could not wear the dentures, the taste was "horrible". On (b)(6) 2015 the patient contacted the dentist and stated he stopped wearing the dentures because his mouth was too sore. The dentist then had the patient come into his office. The dentist reported that both the maxillary and mandibular of the patient were broke out with ulcers, the mandibular arch was the worse. The dentist stated he removed the lynal and had the patient rinse with salt water. The patient was seen again on (b)(6) 2015 and the ulcers were clear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515379-2015-00050 |
| MDR Report Key | 5022406 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-08-21 |
| Date of Report | 2015-07-22 |
| Date of Event | 2015-07-13 |
| Date Mfgr Received | 2015-07-22 |
| Date Added to Maude | 2015-08-21 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494229 |
| Manufacturer G1 | DENTSPLY CAULK |
| Manufacturer Street | 38 W. CLARK AVE. |
| Manufacturer City | MILFORD DE 19963 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19963 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LYNAL TISSUE CONDITIONER AND TEMPORARY RELINER |
| Generic Name | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
| Product Code | EBI |
| Date Received | 2015-08-21 |
| Returned To Mfg | 2015-07-23 |
| Catalog Number | 653006 |
| Lot Number | 150701 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY CAULK |
| Manufacturer Address | 38 W. CLARK AVE. MILFORD DE 19963 US 19963 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-21 |