MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-03 for ITRACK 250A IT-250A manufactured by Ellex Iscience, Inc.
[5048948]
Two devices from same lot were removed from the packaging and were found to be missing a seal on the sterile barrier pouch and therefore were not sterile. Both devices were detected as not sterile prior to use and were not used for surgery.
Patient Sequence No: 1, Text Type: D, B5
[12515884]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005641545-2014-00003 |
| MDR Report Key | 4258667 |
| Report Source | 05 |
| Date Received | 2014-09-03 |
| Date of Report | 2014-08-28 |
| Date of Event | 2014-08-12 |
| Date Mfgr Received | 2014-08-12 |
| Device Manufacturer Date | 2014-04-29 |
| Date Added to Maude | 2014-11-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LISA SIMS |
| Manufacturer Street | 4055 CAMPBELL AVENUE |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6504212757 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 3005641545-08/11/14-001R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ITRACK 250A |
| Generic Name | OPHTHALMIC MICROCATHETER, MPA, MHX |
| Product Code | MPA |
| Date Received | 2014-09-03 |
| Returned To Mfg | 2014-08-20 |
| Model Number | ITRACK |
| Catalog Number | IT-250A |
| Lot Number | 1404-03 |
| ID Number | (01)00893872001059 |
| Device Expiration Date | 2014-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELLEX ISCIENCE, INC |
| Manufacturer Address | 4055 CAMPBELL AVENUE MENLO PARK CA 94025 US 94025 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-03 |