MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-27 for RELYX LUTING PLUS CEMENT 3525 manufactured by 3m Espe Dental Products.
[73892816]
Engineering investigation was limited due to lack of returned product and lot number information. The cause of the patient's symptoms is unknown; multiple products were used during the dental appointment. This product contains potassium persulfate, which can trigger an allergic respiratory reaction in certain individuals. Also, in the un-cured state, this product contains methacrylate resins which can trigger an allergic reaction in individuals with sensitivities to acrylic-based materials. Information about these potential reactions are already provided in the product instructions for use.
Patient Sequence No: 1, Text Type: N, H10
[73892817]
On (b)(6) 2017, a dentist reported that a (b)(6) female patient experienced breathing difficulty upon use of 3m espe relyx luting plus cement to seat crown on tooth #3. Just prior to the crown seating, the patient also had a composite restoration procedure performed on tooth #2. Other products used included an anesthetic, a prophy paste, and a non-3m brand composite material. The dental office administered oxygen and called for emergency medical assistance. The paramedic administered the epipen that the patient normally carries. The patient was then taken to the er, was admitted for observation and was discharged the next day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2017-00038 |
| MDR Report Key | 6528540 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-27 |
| Date of Report | 2017-04-07 |
| Date of Event | 2017-04-06 |
| Date Mfgr Received | 2017-04-07 |
| Date Added to Maude | 2017-04-27 |
| 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 | 2017-04-27 |
| Catalog Number | 3525 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-04-27 |