MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-09 for ITRACK 250A IT-250A 200478 manufactured by Ellex Iscience Inc..
[144669686]
As soon as ellex i. Science became aware of the event, the physician was contacted by ellex chief medical officer for further details. The patient had developed a severe inflammatory reaction immediately following canaloplasty but has been improving. The device lot had passed all device performance and sterility tests prior to release. The concerned device was requested back from the user and is under further evaluation. A follow up report shall be provided with updates on the patient status and device investigation. Review of the lot history record for itrack lot# 1810-05 finds that these were built using approved material and released procedures by trained operators. No anomalies were reported.
Patient Sequence No: 1, Text Type: N, H10
[144669687]
Doctor reported that the patient on whom he performed the canaloplasty, developed severe inflammatory reaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005641545-2019-00001 |
| MDR Report Key | 8597977 |
| Date Received | 2019-05-09 |
| Date of Report | 2019-05-28 |
| Date of Event | 2019-04-09 |
| Date Mfgr Received | 2019-05-22 |
| Device Manufacturer Date | 2018-10-03 |
| Date Added to Maude | 2019-05-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS VERONICA SANZ |
| Manufacturer Street | 41316 CHRISTY ST |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer G1 | ELLEX ISCIENCE INC |
| Manufacturer Street | 41316 CHRISTY ST |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94538 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ITRACK 250A |
| Generic Name | CANNULA, OPHTHALMIC |
| Product Code | HMX |
| Date Received | 2019-05-09 |
| Returned To Mfg | 2019-04-12 |
| Model Number | IT-250A |
| Catalog Number | 200478 |
| Lot Number | 1810-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELLEX ISCIENCE INC. |
| Manufacturer Address | 41316 CHRISTY ST FREMONT CA 94538 US 94538 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-05-09 |