MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-29 for 25+ TOTALPLUS VITRECTOMY PAK 8065751462 manufactured by Alcon Laboratories, Inc..
[41318641]
Patient Sequence No: 1, Text Type: N, H10
[41318642]
While loading the pack in the machine, the machine kept alarming "overfill" and would not let staff move on from the screen and machine froze. Restarted machine and installed a new pack to complete procedure without difficulty manufacturer response for 25+ totalplus vitrectomy pak, 25+ totalplus vitrectomy pak (per site reporter): manufacturer provided shipping instructions and tracking#.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5531234 |
| MDR Report Key | 5531234 |
| Date Received | 2016-03-29 |
| Date of Report | 2016-03-18 |
| Date of Event | 2016-03-03 |
| Report Date | 2016-03-18 |
| Date Reported to FDA | 2016-03-18 |
| Date Reported to Mfgr | 2016-03-18 |
| Date Added to Maude | 2016-03-29 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 25+ TOTALPLUS VITRECTOMY PAK |
| Generic Name | VITRECTOMY, INSTRUMENT CUTTER, LIGHT CORD |
| Product Code | MLZ |
| Date Received | 2016-03-29 |
| Returned To Mfg | 2015-03-18 |
| Catalog Number | 8065751462 |
| Lot Number | 1794148H |
| Device Expiration Date | 2017-08-01 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON LABORATORIES, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-29 |