MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-17 for 25G FLEXIBLE TIP LASER PROBE manufactured by Alcon Research, Llc (formerly Known As Alcon Research Ltd.).
Report Number | MW5087420 |
MDR Report Key | 8707766 |
Date Received | 2019-06-17 |
Date of Report | 2019-06-13 |
Date of Event | 2019-06-07 |
Date Added to Maude | 2019-06-18 |
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 | 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 | 0 |
Brand Name | 25G FLEXIBLE TIP LASER PROBE |
Generic Name | LASER OPHTHALMIC |
Product Code | HQF |
Date Received | 2019-06-17 |
Lot Number | 17013666X |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ALCON RESEARCH, LLC (FORMERLY KNOWN AS ALCON RESEARCH LTD.) |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-06-17 |