MAUDE Adverse Event Report: RELIANCE ORTHODONTIC PRODUCTS, INC. LIQUID ETCHANT

Catalog Number EL24

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2022

Event Type  malfunction  

Manufacturer Narrative

Bisco, inc.Was made aware on 2/8/2022 of an event involving reliance orthodontics products inc.(ropi) liquid etchant lot 214167 manufactured by bisco, inc.For ropi (the labeled manufacturer) item number o-27003r, lot 2100004167.The lot was made to specification with no deviations from the dmr.All raw materials used in the lot met their specification.There were no abnormalities or deviations on the dhr, the device was manufactured to ropi's specification.The critical component of the etchant is 1-phosa85, 85% phosphoric acid which enables the etching mechanism.Lot 2100000575 of 1-phosa85 was used in the manufacture of etchant o-27003r (lot 2100004167) and met its qc specification.The event was not the result of device malfunction.As the etchant is 37% phosphoric acid it is caustic.The device's risk management file (rm-r2002) does identify the risk to skin and soft tissue and this complaint/event does not identify any new risks.Direct exposure to skin or soft tissue can result in burns and is a known risk.The device is prescription only, sold to and only used by trained licensed professionals who are aware of the risk to skin and soft tissue.The device sds does indicate proper measures to take if skin contact should occur, "rinse skin with water." the licensed practitioner should have rinsed the skin with water if they thought contact was made and when consulted should have instructed that the area be rinsed with water.As the etching mechanism relies on the caustic ph of the device of burns to skin and soft tissue cannot be completely mitigated and is a known residual risk.This risk should be clearly marked on the device label with the proper ghs symbol, as used on the device's sds, to alert the user of the hazards.As ropi is the legal manufacturer of the device it is their responsibility to determine the reportability and if required report the event.This report was previously submitted by ropi in the initial reporting timeframe, but monitoring of the maude database and correspondence with the esg helpdesk proved it was not properly received by the fda.Ropi has chosen to resubmit at this time based on this discovery.

Event Description

Reliance contacted the orthodontist after being notified of the patient incident that occurred (b)(6) 2022.The doctor explained that he performed the bonding procedure, etched the patient's teeth with reliance liquid etch, rinsed and dried, and then used a 3m l-pop on her teeth.As he was placing brackets on the teeth when he was preparing to place a bracket on the patient's lower left tooth # 3, he noticed it did not look "frosty" (etched).He then placed some more reliance liquid etch on the tooth rinsed and dried and applied the 3-m l-pop and possibly, inadvertently got some on the patient's cheek or it could have been the 3m l-pop.He received a call from the patient's mother later that day that her daughter was experiencing a burning sensation on her cheek and redness.He then sent the sds for reliance liquid etch and 3-m l-pop to the mother via email.Orthodontist was not aware that any product (reliance or 3m) contacted the patient's skin during treatment, thus the area was not rinsed or washed.Product was not returned as the doctor stated the product worked as intended.

• Brand Name: LIQUID ETCHANT
• Type of Device: LIQUID ETCHANT
• Manufacturer (Section D): RELIANCE ORTHODONTIC PRODUCTS, INC.; 1540 w thorndale ave; itasca IL 60143
• Manufacturer (Section G): BISCO, INC.; 1100 w irving park rd; schaumburg IL 60193
• Manufacturer Contact: ryan hobson ; 1100 w irving park rd; schaumburg, IL 60193 ; 8475346000
• MDR Report Key: 16103676
• MDR Text Key: 308658279
• Report Number: 0001420089-2022-00001
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K875143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EL24
• Device Lot Number: 214167
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR
• Patient Sex: Female