MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2015-06-29 for COE-SOFT 344011 manufactured by Gc America, Inc..
[21189442]
Dental assistant was opening a new bottle of coe-soft liquid and when she placed it on the counter the liquid splashed in her face. She was not wearing goggles and the liquid had gotten into her eyes. She was immediately given treatment in the dental office and was placed under an eyes wash station for 20 minutes. After the eye wash she then went to an immediate care facility. As a precaution, the physician prescribed steroid eye drops. As of (b)(6) 2015 the patient had not gotten her prescription yet.
Patient Sequence No: 1, Text Type: D, B5
[21247364]
Instructions for use have been revised to include additional ppe. Sds has been reviewed and is confirmed to be accurate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1410097-2015-00002 |
| MDR Report Key | 4892372 |
| Report Source | 05,08 |
| Date Received | 2015-06-29 |
| Date of Report | 2015-06-10 |
| Date of Event | 2015-05-14 |
| Device Manufacturer Date | 2015-01-12 |
| Date Added to Maude | 2015-07-07 |
| 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 Street | 3737 WEST 127TH ST. |
| Manufacturer City | ALSIP IL 60803 |
| Manufacturer Country | US |
| Manufacturer Postal | 60803 |
| Manufacturer Phone | 7089263090 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COE-SOFT |
| Generic Name | COE-SOFT PROFESSIONAL PACKAGE |
| Product Code | EBI |
| Date Received | 2015-06-29 |
| Catalog Number | 344011 |
| Lot Number | 1501121 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GC AMERICA, INC. |
| Manufacturer Address | 3737 WEST 127TH ST. ALSIP IL 60803 US 60803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-29 |