MAUDE Adverse Event Report: HERAEUS KULZER GMBH GLUMA DESENSITIZER; AGENT, TOOTH BONDING, RESIN

Catalog Number 65872354

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 09/02/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Evaluation summary: directions for use indicate rubber dam use is required.The office failed to ensure isolation, thereby gluma desensitizer came into contact with the patient's soft tissue.Device not returned.

Event Description

By way of (b)(6), email from (b)(6) territory rep regarding her husband, (b)(6), who had gluma desensitizer placed during prophy appointment on #24,#25 recession.Wife/rep sent photos, showing discolored soft tissue.(b)(4) responded to wife, i am very sorry to hear of his situation.Is he experiencing discomfort? what was the date of his appointment? has he been treated with anything else to try to mitigate the symptoms? directions for use for gluma desensitizer state "protect mucous membranes by using a rubber dam.Make sure that gluma desensitizer only comes into contact with area to be treated." the product is caustic to soft tissue and can cause chemical burns.For medical advice, please refer back to your dentist or another qualified medical provider.If i may be of assistance, do not hesitate to contact me.Wife responded that husband was in a ton of pain but had not been treated with anything else.(b)(4) left message at dental office asking for return call, preferably from the practitioner and left (b)(4)'s contact information.(b)(4) lm again for practioner to return call.(b)(4) three hours later, advised wife/rep that there had been no response from the office.(b)(4) call from (b)(6) from office.Person who worked on (b)(6) is not due back until tomorrow.(b)(6) will have her call me then.(b)(4) no further contact was received from office.This is a serious injury (as defined in 21 cfr section 803.3) as the patient reported having an adverse reaction.Because the malfunction allegation could not be confirmed, the cause of the adverse reaction could not be determined.This incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.

• Brand Name: GLUMA DESENSITIZER
• 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: 5101424
• MDR Text Key: 26719757
• Report Number: 9610902-2015-00014
• 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: consumer,distributor
• Reporter Occupation: Patient Family Member or Friend
• Report Date: 09/04/2015

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 Hygienist
• Device Catalogue Number: 65872354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/04/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 35 YR