MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-09-29 for RELYX LUTING PLUS AUTOMIX CEMENT 3535 manufactured by 3m Espe Dental Products.
[87840169]
Engineering investigation was limited due to lack of returned product and lot number information. The 3m subject product has been evaluated for biocompatibility and is safe for intended use. In addition, the instructions for use (ifu) contains precautionary information about potential allergic reaction following oral soft tissue or skin contact with the product.
Patient Sequence No: 1, Text Type: N, H10
[87840170]
A dentist reported that a (b)(6) male patient experienced an allergic reaction that included lip swelling and gingival tissue sloughing following use of 3m espe relyx luting plus automix cement to place 6 porcelain-fused-to-metal crowns on (b)(6) 2017. The patient sought medical attention that same evening, at an emergency room, and was treated with iv steroids (unknown) and benadryl. The dentist saw the patient 12 days later and the symptoms had resolved. The denist reported that the cement was overloaded on the crowns and came in contact with the gums and gingival tissue, and he believes that caused the reaction. Latex gloves were also used during the appointment, but it is unknown if latex may have contributed to the symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2017-00047 |
| MDR Report Key | 6906290 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-09-29 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-09-07 |
| Date Mfgr Received | 2017-09-19 |
| Date Added to Maude | 2017-09-29 |
| 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 | 2017-09-29 |
| Catalog Number | 3535 |
| 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 | 2017-09-29 |