MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS RELYX LUTING LUTING CEMENT; DENTAL CEMENT

Catalog Number 3505

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Occlusion (1984); Rash (2033); Swelling (2091); Loss of consciousness (2418)

Event Date 10/13/2015

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: RELYX LUTING LUTING CEMENT
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS; 2510 conway avenue; st. paul MN 55144 1000
• Manufacturer (Section G): 3M ESPE DENTAL PRODUCTS-IRVINE; 2111 mcgaw avenue; irvine CA 92614
• Manufacturer Contact: angie draper ; 2510 conway avenue; st. paul, MN 55144-1000 ; 6517331179
• MDR Report Key: 5317238
• MDR Text Key: 34069784
• Report Number: 3005174370-2015-00131
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K933139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 3505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention