MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-08 for TONOMETRY manufactured by .
[5819251]
(b)(6). I would like to report that tonometry devices cannot be properly disinfected. It has been documented that ebola can remain live in patient's eye. There is no way because of the design of the tonometry device that it can be properly disinfected. It has direct contact with patient's body fluids, and is used multiple times a day without proper disinfecting. I know that the fda is actively involved in reproducing reusable medical device issues, and would recommend that this device also be evaluated. You will notice in the photographs that the ophthalmologist was not wearing gloves while examining the patient and would potentially touch body fluids from patients' eyes. Instrument touches patient's eye as well which had active ebola virus in it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042726 |
| MDR Report Key | 4777241 |
| Date Received | 2015-05-08 |
| Date of Report | 2015-05-08 |
| Date Added to Maude | 2015-05-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TONOMETRY |
| Generic Name | TONOMETRY |
| Product Code | HKX |
| Date Received | 2015-05-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Deathisabilit | 2015-05-08 |