MAUDE Adverse Event Report: HERAEUS KULZER GMBH IBOND TOTAL ETCH; AGENT, TOOTH BONDING, RESIN

Catalog Number 66040094

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is a serious injury (as defined in 21 cfr section 803.3) as the patient (staff member) reported having an adverse reaction.Because the malfunction allegation could not be confirmed, the cause of the adverse reaction could not be determined.Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution.Directions for use say place ibond total etch in a dappen dish, pick it up with an applicator tip or a soft disposable brush and apply it generously to the complete surface of the cavity.Also: contact with skin or mucous membranes may cause irritation or sensation.Prevent contact with skin, mucous membranes and eyes by taking precautions.Device not returned.

Event Description

Da at dental office reports wound on back of hand which will not heal.Da has noticed this since shortly after switching to ibond te from gbond.Da is using nitrile gloves and using the back of her hand as a well in lieu of using a dappen dish.Asked hk rep to recommend the da seek medical attention asap and stop using the back of her hand as a well.Explained the product is designed with solvents to penetrate enamel and dentin.Reviewed dfu, which states: place ibond total etch in a dappen dish, pick it up with an applicator tip or a soft disposable brush and apply it generously to the complete surface of the cavity.Also: contact with skin or mucous membranes may cause irritation or sensation.Prevent contact with skin, mucous membranes and eyes by taking precautions.On (b)(6) 2015 da called.(b)(4) explained the product is designed with solvents to penetrate enamel and dentin.(b)(4) insisted she stop using the back of her hand, and that she tell others who also might be using product this way that application is not in the dfu.Recommended the office use the wells that come with the product.(b)(4) also encouraged da to seek medical attention from a dermatologist for her hand.(b)(6) declined, saying she had just been to the dermatologist several weeks ago for a general exam, not specifically for her hand.Da has not sought medical attention for this wound.

• Brand Name: IBOND TOTAL ETCH
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): HERAEUS KULZER GMBH; philipp-reis-strasse 8/13; wehrheim, D-612 73; GM D-61273
• Manufacturer (Section G): HERAEUS KULZER GMBH; philipp-reis-strasse 8/13; wehrheim, D-612 73; GM D-61273
• Manufacturer Contact: rita rogers ; 300 heraeus way; south bend, IN 46614 ; 5742995409
• MDR Report Key: 5192392
• MDR Text Key: 30058402
• Report Number: 9610902-2015-00017
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dental Assistant
• Type of Report: Initial
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Assistant
• Device Catalogue Number: 66040094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/22/2015
• Initial Date Manufacturer Received: 10/22/2015
• Initial Date FDA Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other