MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-08-09 for WHITE STAR HIGH SPEED VIT CUTTER NGP0025 manufactured by Johnson & Johnson Surgical Vision, Inc.
[116598731]
(b)(6). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[116598732]
A surgery center reported mislabeling on two disposable vitrectomy cutters. A brief description from the surgery center indicated they ordered size 25-gauge disposable vitrectomy cutters but upon opening the package, the actual vitrectomy cutter had size 20-gauge engraved on the device. No indication of patient contact. This is 2 of 2 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2018-01652 |
| MDR Report Key | 7767455 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-09 |
| Date of Report | 2018-10-05 |
| Date of Event | 2018-07-13 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2018-09-19 |
| Device Manufacturer Date | 2017-09-21 |
| Date Added to Maude | 2018-08-09 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LOURDES GUEVARA |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478497 |
| Manufacturer G1 | JOHNSON & JOHNSON SURGICAL VISION, INC |
| Manufacturer Street | 510 COTTONWOOD DRIVE |
| Manufacturer City | MILPITAS CA 95035 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95035 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WHITE STAR HIGH SPEED VIT CUTTER |
| Generic Name | DISPOSABLE VITRECTOMY CUTTER |
| Product Code | MLZ |
| Date Received | 2018-08-09 |
| Returned To Mfg | 2018-08-10 |
| Model Number | NGP0025 |
| Catalog Number | NGP0025 |
| Lot Number | 60087423 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON SURGICAL VISION, INC |
| Manufacturer Address | SANTA ANA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-09 |