MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-04-12 for ZOE B&T 610102 manufactured by Dentsply Caulk.
[602034]
It was reported that liquid splashed into a dental assistant's eye after the bottle was dropped into a sink while preparing for a root canal procedure; redness was noted and discomfort was experienced when blinking, though sight was not affected. The assistant flushed the eye with water and sought treatment from a dr, who administered artificial tears and had the assistant flush the eye with water again. Additionally, the dr advised the assistant to refrain from working for a day. Ultimately, the assistant opted to return to work and developed a bacterial infection in the eye, for which the dr administered eye drops (the type is unknown, though the drops are presumed to contain an antibiotic). The assistant indicated that the dr feels the infection developed as a result of returning to work.
Patient Sequence No: 1, Text Type: D, B5
[7961272]
Though the device did not malfunction in this event, the assistant did require antibiotic eye drops to preclude permanent damage to a body structure or permanent impairment of a body function. The device was not returned for eval and the lot number is not known for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515379-2007-00076 |
| MDR Report Key | 838085 |
| Report Source | 05 |
| Date Received | 2007-04-12 |
| Date of Report | 2007-03-13 |
| Date of Event | 2007-03-12 |
| Date Mfgr Received | 2007-03-13 |
| Date Added to Maude | 2007-04-18 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | SUSQUEHANNA COMMERCE CENTER W 221 W PHILA ST, STE 60 |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY CAULK |
| Manufacturer Street | 38 W CLARK AVE |
| Manufacturer City | MILFORD DE 19963 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19963 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOE B&T |
| Generic Name | EMB |
| Product Code | EMB |
| Date Received | 2007-04-12 |
| Model Number | NA |
| Catalog Number | 610102 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 825388 |
| Manufacturer | DENTSPLY CAULK |
| Manufacturer Address | * MILFORD DE * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-04-12 |