MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2016-07-14 for RELYX LUTING PLUS CEMENT 3525TK manufactured by 3m Espe Dental Products.
[49620229]
The patient's history suggests a known reaction to artificial fingernails. Such a reaction is often consistent with an allergy to acrylates. As sold, relyx luting cement contains methacrylate monomers; many patients who have allergy to acrylates experience a cross-reaction to methacrylates. For this reason, the product instructions for use contain a warning statement to avoid use in patients with known acrylate allergy.
Patient Sequence No: 1, Text Type: N, H10
[49620230]
On (b)(6) 2016, a (b)(6) female patient reported she experienced an allergic reaction (symptoms of numbness and roughness of tissues on the left side of her mouth accompanied by throat swelling). These symptoms began after (b)(6) 2016, placement of a non-3m crown on tooth #14 using 3m espe relyx luting plus cement. The patient was treated at an emergency room with an injection of benadryl? And released. Several days later, the patient developed what was described as canker sores in the soft tissue adjacent to the crown; a dexamethasone mouth rinse was prescribed and the sores resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2016-00073 |
| MDR Report Key | 5797079 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2016-07-14 |
| Date of Report | 2016-06-17 |
| Date of Event | 2016-06-16 |
| Date Mfgr Received | 2016-06-17 |
| Date Added to Maude | 2016-07-14 |
| 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 CEMENT |
| Generic Name | DENTAL CEMENT |
| Product Code | EMA |
| Date Received | 2016-07-14 |
| Catalog Number | 3525TK |
| Lot Number | N718885 |
| Operator | DENTIST |
| Device Availability | N |
| 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 | 2016-07-14 |