MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-12-21 for RELYX LUTING LUTING CEMENT 3505 manufactured by 3m Espe Dental Products.
[34069784]
Engineering investigation was limited due to lack of returned product and lot number information. The role that the patient's pre-existing medical conditions and several concurrent medications may have played in this case is unknown. In the un-cured state, this product contains methacrylate resins which can trigger an allergic reaction in individuals with sensitivities to acrylic-based materials, which this patient reports. This product also contains potassium persulfate, which can trigger an allergic respiratory reaction in certain individuals. Information about these potential reactions are already provided in the product instructions for use.
Patient Sequence No: 1, Text Type: N, H10
[34069845]
A patient experienced an allergic-type reaction after six crowns were cemented with 3m espe relyx luting cement on (b)(6) 2015. Within two hours, the patient noticed lower lip swelling and itchy blotches on her chin. The reaction progressed and on (b)(6) 2015, the patient experienced throat tightness, felt out of balance, and lost consciousness. The patient gave herself an injection with epipen(r) and called 911; however, when paramedics arrived she had improved and requested that she not be transported. About 2-3 hours later, the patient developed recurring swelling beneath her chin and shortness of breath; patient sought help at an emergency room. In the er, the patient was administered prednisone, benadryl, and more epinephrine. The patient was referred to an allergist who prescribed zyrtec (antihistamine) for the hives and itching, a hydrocortisone cream for the rash, and an epipen in case the reaction reoccurs. The allergist also stated that the patient may have a sensitivity to potassium persulfate, a component of the subject cement. The treating dentist has volunteered to remove her crowns if the patient's reaction is determined by the allergist to be the result of the subject cement; however, the dentist reported he does not feel it is related to the cement since the patient's intra-oral exam showed no issues; soft tissue looked healthy upon placement. The dentist also stated that he does not feel it is due to the acrylates in the cement since he placed a temporary restoration with an acrylic cement previously and saw no reaction. The patient was reported by the dentist to be "virtually asymptomatic" on (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2015-00131 |
| MDR Report Key | 5317238 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-12-21 |
| Date of Report | 2015-12-02 |
| Date of Event | 2015-10-13 |
| Date Mfgr Received | 2015-12-02 |
| Date Added to Maude | 2015-12-21 |
| 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 | 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 LUTING CEMENT |
| Generic Name | DENTAL CEMENT |
| Product Code | EMA |
| Date Received | 2015-12-21 |
| Catalog Number | 3505 |
| 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 | 2015-12-21 |