MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-06-01 for RELYX LUTING PLUS AUTOMIX CEMENT 3535TK manufactured by 3m Espe Dental Products.
[46358897]
One relyx luting plus automix syringe was returned for analysis, lot #n749297, exp. 2017-11. Analysis showed that both paste a and paste b extruded as expected. Since there was not enough paste remaining in the returned sample, a retain sample from the same lot was analyzed for set time and was found to be within specification; no other complaints were found for this lot number. The effect of other products used as potentially contributing to the patient's symptoms is unknown. This product contains methacrylate resins which can trigger an allergic reaction in individuals with sensitivities to acrylic-based materials. This product also contains potassium persulfate which can trigger an allergic respiratory reaction in certain individuals. The instructions for use for relyx luting plus automix cement and safety data sheet both contain a warning for potential reaction.
Patient Sequence No: 1, Text Type: N, H10
[46358898]
A dentist reported a female patient experienced swelling, itchiness and redness of the upper mucosa after placement of four jensen xt zirconia crowns in the maxillary anterior (in areas #6, 7, 8, and 10) using 3m espe relyx luting plus automix. On (b)(6) 2016, 3m espe learned that the patient sought additional medical treatment at a hospital on (b)(6) 2016 for her symptoms, which included a steroid injection and prescription for predinsone. Later the same day, the dentist removed all four crowns and replaced them with provisional acrylic crowns and instructed the patient to continue with the medication prescribed by the physician and to see an allergist. The patient was reported to be improving and asymptomatic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2016-00061 |
| MDR Report Key | 5693155 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-06-01 |
| Date of Report | 2016-05-05 |
| Date of Event | 2016-03-29 |
| Date Mfgr Received | 2016-05-05 |
| Date Added to Maude | 2016-06-01 |
| 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 | ANGIE DRAPER |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517331179 |
| Manufacturer G1 | 3M ESPE DENTAL PRODUCTS-IRVINE |
| Manufacturer Street | 2111 MCGAW AVENUE |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELYX LUTING PLUS AUTOMIX CEMENT |
| Generic Name | DENTAL CEMENT |
| Product Code | EMA |
| Date Received | 2016-06-01 |
| Returned To Mfg | 2016-05-10 |
| Catalog Number | 3535TK |
| Lot Number | N749297 |
| Device Expiration Date | 2017-11-30 |
| Operator | DENTIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Address | 2510 CONWAY AVENUE ST. PAUL MN 551441000 US 551441000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-01 |