MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH 3M ESPE KETAC CEM EASYMIX; CEMENT, DENTAL, GLASSIONOMER

Catalog Number 56900

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Anaphylactoid (2218); Patient Problem/Medical Problem (2688)

Event Date 11/08/2016

Event Type  Injury  

Manufacturer Narrative

At the date of this report it remains unclear if ketac cem easymix really caused the anaphylactic shock.The time elapsed between the dental treament and the beginning of the anaphylactic shock (several hours) and the clinical history of the product (an allergic reaction to it was never proven before) are arguments against a correlation.The dentist reported us the case in order to get the full composition of the product as the patient wants to have tested all possible causes of the adverse event.However, at the moment it can't be fully excluded that ketac cem easymix was involved in the incident and therefore the case is reported.

Event Description

On (b)(6) 2016 3m (b)(4) was informed of an anaphylactic shock that occurred in a male patient after the use of the dental cement 3m espe ketac cem easymix.The reaction took place on (b)(6) 2016, some hours after the dental treatment.The patient was administered to a hospital, where he stayed for two weeks.After this he left the hospital without any ongoing symptoms.At the date of this report it is unclear if the product really caused the reaction.

• Brand Name: 3M ESPE KETAC CEM EASYMIX
• Type of Device: CEMENT, DENTAL, GLASSIONOMER
• 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: 6196840
• MDR Text Key: 63055183
• Report Number: 9611385-2016-00013
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K002793
• 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: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 56900
• Device Lot Number: 639347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 25 YR