MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-22 for TRABECTOME? DRAPING SYSTEM 600018-04 manufactured by Neomedix Corporation.
[136854886]
Prior to the surgical procedure, when the surgeon went to use it, stated he was not happy with the way the tip was formed. The surgeon refused to use the device and it was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8361205 |
| MDR Report Key | 8361205 |
| Date Received | 2019-02-22 |
| Date of Report | 2019-02-13 |
| Date of Event | 2019-01-22 |
| Report Date | 2019-02-13 |
| Date Reported to FDA | 2019-02-13 |
| Date Reported to Mfgr | 2019-02-22 |
| Date Added to Maude | 2019-02-22 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | TRABECTOME? DRAPING SYSTEM |
| Generic Name | DRAPE, SURGICAL |
| Product Code | KKX |
| Date Received | 2019-02-22 |
| Model Number | 600018-04 |
| Catalog Number | 600018-04 |
| Lot Number | 170726-02 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOMEDIX CORPORATION |
| Manufacturer Address | 15042 PARKWAY LOOP, SUITE A TUSTIN CA 92780 US 92780 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-22 |