MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-06-15 for DARBY TEMPORARY CEMENT SOLUTION 50036456 manufactured by Heraeus Kulzer, Llc.
[17539161]
By way of (b)(6), male darby dental rep called from (b)(6), asking for sds of darby temporary cement solution. He was calling on behalf of a customer who had splashed it in her eye. She was enroute to hospital and wanted the information on her phone when she arrived. I forwarded the sds to (b)(4). No further details were provided. 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
[17829979]
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. Eye contact is addressed in the directions for use. The directions state, "concentrated detergent mixture contains sodium hydroxide. May cause skin or eye irritation. Harmful if swallowed. In case of contact, flush eyes or skin with plenty of water. If irritation persists, seek medical attention. " no failure of the medical device was detected. Eye irritation is a known inherent risk of using this medical device, and user error in failing to use adequate eye protection contributed to this event. Product was not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1821514-2015-00025 |
| MDR Report Key | 4844224 |
| Report Source | 08 |
| Date Received | 2015-06-15 |
| Date of Report | 2015-06-08 |
| Date of Event | 2015-06-08 |
| Date Mfgr Received | 2015-06-08 |
| Date Added to Maude | 2015-06-15 |
| 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 |
| 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, LLC |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614251 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46614 2517 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DARBY TEMPORARY CEMENT SOLUTION |
| Generic Name | CLEANER, ULTRASONIC, MEDICAL INSTRUMENT |
| Product Code | CEK |
| Date Received | 2015-06-15 |
| Catalog Number | 50036456 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER, LLC |
| Manufacturer Address | 300 HERAEUS WAY SOUTH BEND IN 46614251 US 46614 2517 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-15 |