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

Catalog Number 3535

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

Patient Problem Anaphylactic Shock (1703)

Event Type  Injury  

Manufacturer Narrative

Engineering investigation was limited due to lack of returned product and lot number information.This event involved two 3m espe medical devices, therefore two manufacturer medwatch reports are being submitted.This medwatch report provides information on the second medical device.Manufacturer report 9611385-2016-00003 provides information on the first medical device.Both 3m subject products have been evaluated for biocompatibility and are safe for their intended use.Without additional information on patient medical history, the cause of the reported reaction cannot be determined.Relyx luting plus automix cement contains potassium persulfate which can trigger an allergic respiratory reaction in certain pre-sensitized individuals (those individuals already sensitized to sulfites).The instructions for use for relyx luting plus automix cement and safety data sheet both contain a warning for the potential cross-reaction.In the last seven years, 3m has received only three other reports of possible respiratory reaction for the product.

Event Description

A medical office reported a (b)(6) patient experienced anaphylactic shock after use of 3m espe scotchbond universal adhesive and 3m espe relyx luting plus automix cement.Contact information for the medical office was inadvertently not obtained during the call.3m contacted the treating dental office and they were unable to identify the patient involved in this case; therefore no further information is available, and the relationship of the symptoms reported to use of the 3m subject products cannot be established.

• Brand Name: RELYX LUTING PLUS AUTOMIX 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: 5487670
• MDR Text Key: 39928717
• Report Number: 3005174370-2016-00031
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• PMA/PMN Number: K111185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 3535
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 59 YR