MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH 3M (TM) ESPE (TM) CAVIT (TM); DENTAL CEMENT

Catalog Number 44030

Device Problem Insufficient Information (3190)

Patient Problems Urticaria (2278); Loss of consciousness (2418)

Event Date 08/14/2013

Event Type  Injury  

Event Description

On (b)(6) 2013, 3m espe was informed about an adverse event that occurred after 3m, espe, cavit was used together with other dental products.One pt got a dental root treatment on (b)(6).Within 24 hours the pt developed hives and the next day the pt did pass out while he was having breakfast.The pt was transported by ambulance to the emergency room where he was treated.In the meantime the pt is doing well, hives have lessened but are still present.At the date of this report it is not clear if cavit has caused the symptoms.

Manufacturer Narrative

Method, results and conclusion: no product was returned to 3m espe for evaluation until the date of this report.An interview was conducted to the pt's doctor.The doctor spoke to the md and the md diagnosed a drug reaction.The pt just finished a penicillium prescription several days before the dental treatment.Another product used in the dental treatment was the local anaesthetic cetacaine.The pt had other root canal treatments before with any reaction.These data make an allergic reaction to cavit questionable.This product has been assessed for biocompatibility and has been found to be safe for its intended use.It is a long time in the market and has a favorable clinical use history, in which only two other reports of hospitalization after use has been received by 3m espe in 2008 (9611385-2008-00006) and 2012 (9611385-2012-00004).

• Brand Name: 3M (TM) ESPE (TM) CAVIT (TM)
• Type of Device: DENTAL CEMENT
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; seefeld, bavaria ; GM
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH; carl-schurz-strasse 1; neuss 4145 3; GM 41453
• Manufacturer Contact: thomas meindl ; espeplatz; seefeld, bavaria 82229 ; GM 82229 ; 1527001327
• MDR Report Key: 3608904
• MDR Text Key: 18855687
• Report Number: 9611385-2013-00014
• Device Sequence Number: 1
• Product Code: EBG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K875133
• 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: 08/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 44030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2012
• 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