MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-05-07 for GLUMA ETCH 35 FLUID 15ML FL 66000129 manufactured by Heraeus Kulzer Gmbh.
[21330531]
(b)(6) called because he said he placed some gluma etch 35% fluid on a patients tooth and when he rinsed it off, a little got into his patient's eye. He asked what he should do. I read from the msds, "after eye contact rinse opened eye for several minutes under running water. Then consult a doctor. " he said he did rinse it and she had on sunglasses and wore contacts. I asked if the patient was still in the chair and he said no. I asked if he would like a copy of the msds and he said no. I asked if the patient was going to seek medical attention and he said he didn't know. I asked if i could get some information on the incident to document this and he said that he needed to get off the phone and advise her to see her doctor. On (b)(6) 2015, i called the office back and spoke to eve. I explained who i was and that i was calling to see if the doctor had a moment to speak to me so i could get more information. She said he is busy with a patient right now. I asked if she could at least tell me the percentage and if it was fluid or gel. She said it was the fluid. I asked if she could read me the lot number. I asked if she had spoken to the patient since and if she sought medical attention. She said the patient has not returned any calls. I asked if we could follow up with her in about a week or if she could contact me if she hears from the patient. She said we could call or she will call if she hears anything and took my name and number down. I plugged the lot number into the system after hanging up with eve and realized it expired 9/30/2007. This is a serious injury (as defined in 21 cfr section 803. 3) and requires intervention to prevent potential permanent harm to a body structure. This incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.
Patient Sequence No: 1, Text Type: D, B5
[21622165]
As allowed by exemption # (b)(4), (b)(4) (the importer) is submitting the report on behalf of heraeus kulzer (b)(4) (the manufacturer). 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 avoid contact with the eyes. The office failed to exercise adequate precautions, and the product got in the patient's eye. Also the product expiration date is nearly 8 years past. Device not returned by dentist.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610902-2015-00009 |
| MDR Report Key | 4755334 |
| Report Source | 05 |
| Date Received | 2015-05-07 |
| Date of Report | 2015-04-27 |
| Date of Event | 2015-04-27 |
| Date Facility Aware | 2015-04-27 |
| Date Mfgr Received | 2015-04-27 |
| Device Manufacturer Date | 2004-09-30 |
| Date Added to Maude | 2015-05-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. RITA ROGERS |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995409 |
| Manufacturer G1 | HERAEUS KULZER GMBH |
| Manufacturer Street | PHILIPP-REIS-STRASSE 8/13 |
| Manufacturer City | WEHRHEIM, D-61273 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-61273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLUMA ETCH 35 FLUID 15ML FL |
| Generic Name | ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION |
| Product Code | EBZ |
| Date Received | 2015-05-07 |
| Catalog Number | 66000129 |
| Lot Number | 010284 |
| Device Expiration Date | 2007-09-30 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | 11 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER GMBH |
| Manufacturer Address | PHILIPP-REIS-STRASSE 8/13 WEHRHEIM, D-61273 GM D-61273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2015-05-07 |