MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-20 for BIOTRUE ONE DAY manufactured by Bausch & Lomb, Inc..
| Report Number | MW5089213 |
| MDR Report Key | 8915582 |
| Date Received | 2019-08-20 |
| Date of Report | 2019-08-17 |
| Date of Event | 2019-08-17 |
| Date Added to Maude | 2019-08-21 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | 0 |
| Brand Name | BIOTRUE ONE DAY |
| Generic Name | LENS, CONTACT, (DISPOSABLE) |
| Product Code | MVN |
| Date Received | 2019-08-20 |
| Lot Number | W87228434 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-08-20 |