MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-14 for TEARLAB OSMOLARITY SYSTEM manufactured by Tearlab Inc..
[31580889]
Package insert cannot be read - type is too small for even a magnifying glass - will lead to misuse. Dates of use: (b)(6) 2015. Reason for use: dry eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057943 |
| MDR Report Key | 5235240 |
| Date Received | 2015-11-14 |
| Date of Report | 2015-11-14 |
| Date of Event | 2015-11-13 |
| Date Added to Maude | 2015-11-19 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEARLAB OSMOLARITY SYSTEM |
| Generic Name | TEARLAB OSMOLARITY SYSTEM |
| Product Code | OND |
| Date Received | 2015-11-14 |
| Lot Number | A1039486 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TEARLAB INC. |
| Manufacturer Address | SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-14 |