MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-09-30 for COE-COMFORT ENDENTULOUS TISSUE CONDITIONER 341001 manufactured by Gc America, Inc..
[18933495]
Dental nurse was opening a bottle of coe-comfort liquid when it splashed in her eye causing potential permanent damage. She was not wearing protective safety glasses/goggles. She experienced immediate complications with eye redness, swelling and soreness. Eye washout was done with water in the room. This was followed by eyewash solution from another part of the office. She was then taken to acute medical care.
Patient Sequence No: 1, Text Type: D, B5
[19044263]
Gc america will be revising the instruction sheet to add personal protective equipment - gloves and eyewear required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1410097-2014-00003 |
| MDR Report Key | 4187671 |
| Report Source | 01,05,06 |
| Date Received | 2014-09-30 |
| Date of Report | 2014-09-30 |
| Date of Event | 2014-09-03 |
| Date Mfgr Received | 2014-09-05 |
| Date Added to Maude | 2014-10-22 |
| 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 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-COMFORT ENDENTULOUS TISSUE CONDITIONER |
| Generic Name | RELINE MATERIAL |
| Product Code | EBI |
| Date Received | 2014-09-30 |
| Catalog Number | 341001 |
| Lot Number | 1305101 |
| Device Expiration Date | 2016-05-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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; 2. Required No Informationntervention | 2014-09-30 |