MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-04-16 for NONE manufactured by .
[15327276]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[15635340]
This is a response to the user facility's initial report. The device was returned and visually inspected. Our investigation revealed that the molding process resulted in an incomplete device. Although each of these molded devices completes two quality assurance checks including 100% visual inspection, this device was not detected prior to shipment. We have had no other reports of this nature and believe it to be an isolated incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419727-2014-00001 |
| MDR Report Key | 3856684 |
| Report Source | 06 |
| Date Received | 2014-04-16 |
| Date Mfgr Received | 2014-03-24 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2014-06-27 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 816 NORTH KOSTNER AVE. |
| Manufacturer City | CHICAGO IL 60651 |
| Manufacturer Country | US |
| Manufacturer Postal | 60651 |
| Manufacturer Phone | 7737729570 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NONE |
| Generic Name | NONE |
| Product Code | EYI |
| Date Received | 2014-04-16 |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-16 |