MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH 3M ESPE RELYX ULTIMATE CEMENT; DENTAL CEMENT

Lot Number 656796

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Syncope (1610); Dyspnea (1816); Patient Problem/Medical Problem (2688)

Event Date 04/10/2017

Event Type  Injury  

Manufacturer Narrative

At the moment it is not proven that the symptoms were definitively caused by the dental products as no further information like the results of an allergy testing are available.However, the timely correlation makes such a coincidence possible.The products contain methacrylates, which can cause allergies in very rare cases.Appropriate warnings are present in the instructions for use and in the safety data sheets of the products.This event involved two medical devices, therefore two manufacturer reports are being submitted.This device describes the second device.Manufacturer report number 9611385-2017-00005 describes the first device.

Event Description

On (b)(6) 2017, 3m was notified that a (b)(6) female patient experienced a potential allergic reaction following a dental treatment which included 3m espe scotchbond universal adhesive and 3m espe relyx ultimate cement.The potential allergic reaction occurred at 09.30 a.M.On (b)(6) 2017 shortly after the dental treatment.The symptoms were no feeling in lips and hand, shortness of breath and wheezing, and the patient was losing consciousness.Paramedics were called and the patient was admitted to the hospital.It was reported that that patient received two adrenaline nebulizer treatments.The patient fully recovered by 5 p.M.On the same day.Other dental products, including local anesthetics, were also used during the dental treatment.

• Brand Name: 3M ESPE RELYX ULTIMATE CEMENT
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; carl-schurz-strasse 1; neuss, 41453 ; GM 41453
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH-SEEFELD; espe platz; seefeld, 82229 ; GM 82229
• Manufacturer Contact: thomas meindl ; carl-schurz-strasse 1; neuss, 41453 ; GM 41453
• MDR Report Key: 6559273
• MDR Text Key: 74889360
• Report Number: 9611385-2017-00006
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 07/31/2018
• Device Lot Number: 656796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 29 YR
• Patient Weight: 57