MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS KETAC CEM PLUS AUTOMIX; DENTAL CEMENT

Catalog Number 3536

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

Patient Problems Anaphylactic Shock (1703); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

The product contains an ingredient which can trigger an allergic reaction in those individuals who are pre-sensitized to sulfites.The ifu contains information regarding this cross-reaction.It is also unclear, why the product was used on this patient a second time after a reaction was noted.Because no original material or batch-nos.Were sent to us, no further investigation on the original material or a retained sample could be performed.This product has been evaluated for biocompatibility and found to be safe for its intended use; further, it has a favorable clinical use profile with no other reports of this nature occuring this year.

Event Description

3m (b)(4) was informed on may 9th, 2016, about a medical complaint involving the 3m espe relyx luting plus automix (also known as ketac cem plus automix).It was reported by a hospital that a patient experienced anaphylactic shock twice after the use of the product.According to the reporter, the root cause for the event was an allergy, but it was not specified which substance caused the symptoms.Despite several attempts, the hospital refused to provide further information, so no additional information is available.

• Brand Name: KETAC CEM PLUS AUTOMIX
• 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: 5707666
• MDR Text Key: 46853086
• Report Number: 3005174370-2016-00062
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K111185
• 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: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 3536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other