MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-11-10 for GONOCHEK-II N/A 13-003-25 manufactured by Ey Laboratories (h.k.) Ltd..
[9660]
A confirmed neisseria gonorrhoeae failed to produce a positive (red color) reaction in gonochek-ii.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2917572-1993-00007 |
| MDR Report Key | 10321 |
| Date Received | 1993-11-10 |
| Date of Report | 1993-10-15 |
| Date of Event | 1993-10-05 |
| Date Facility Aware | 1993-10-05 |
| Report Date | 1993-10-15 |
| Date Reported to FDA | 1993-10-15 |
| Date Reported to Mfgr | 1993-10-15 |
| Date Added to Maude | 1993-12-01 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GONOCHEK-II |
| Generic Name | IN-VITRO DIAGNOSTIC TEST-NEISSERIA GONORRHOEAE |
| Product Code | GTH |
| Date Received | 1993-11-10 |
| Model Number | N/A |
| Catalog Number | 13-003-25 |
| Lot Number | 100427 |
| ID Number | N/A |
| Device Expiration Date | 1994-04-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 18 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10321 |
| Manufacturer | EY LABORATORIES (H.K.) LTD. |
| Manufacturer Address | 23 MEI WAN STREET TSEUN WAN NEW TERRITORIES HK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-11-10 |