MAUDE Adverse Event Report: 3M UNITEK; ORTHODONTIC METAL BRACKET, BAND, TUBE, - EJF, ECM, DZD

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Loss of consciousness (2418); Alteration In Body Temperature (2682)

Event Date 04/01/2014

Event Type  Injury  

Event Description

Adult female undergoing orthodontic treatment had an allergic reaction following the bonding of metal bands, tubes and brackets to her teeth.The allergic reaction was reported by the orthodontist as serious, and info about the nickel content in the stainless steel appliances was requested.3m provided the response that these appliances all contain nickel and chromium, and that the product is labeled with a warning directing the pt to consult a physician if an allergic reaction occurs.3m also recommended the removal of the appliances if the pt was confirmed to have an allergy to nickel/chromium.Further info from reporter revealed that the pt had a small allergic reaction after the first step of her treatment, but decided to continue treatment and had a massive allergic reaction including lack of consciousness and fever which resulted in hospitalization.The doctor suggested removal of the appliances but the pt refused.She is currently on steroids treatment.The doctor declined to provide info about the pt or identify the hosp.

Manufacturer Narrative

The doctor could not provide the lot number or name of the appliances used on this pt.He did not purchase the product directly from 3m.The product had been repacked, but he was certain they were 3m products, though he was unable to provide the brand name.

• Brand Name: UNK
• Type of Device: ORTHODONTIC METAL BRACKET, BAND, TUBE, - EJF, ECM, DZD
• Manufacturer (Section D): 3M UNITEK; monrovia CA
• Manufacturer Contact: kathleen bacon ; 2724 south peck rd.; monrovia, CA 91016 ; 6265744212
• MDR Report Key: 3830134
• MDR Text Key: 20293984
• Report Number: 2020467-2014-00001
• Device Sequence Number: 1
• Product Code: EJF
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2014
• 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
• Treatment: BONDING ADHESIVE: UNK
• Patient Outcome(s): Required Intervention