MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 1998-01-13 for SIGNIFY STREP A TEST 6D95-50 manufactured by Wyntek Diagnostics, Inc..
[88089]
On 12/05/1997, the pediatric nursing supervisor at the account splashed her eye with reagent, while teaching a hlth technician how to run the signify strep a test. The hlth technician was wringing the swab against the side of the tube after the extraction steps were performed when the swab came out of the tube and splashed the supervisor in the eye. Both reagent 1 and 2 were in the tube along with the pt swab, from a hlth tech. After the incident, the supervisor immediately flushed her eye at the wash station. A physician examined her eye and stated there may be an abrasion on the surface, possibly caused by burning of the tissue from the chemicals. The physician treated the supervisor with an ophthalmic topical antibiotic solution. On 12/16/1997, further info was rec'd from the account. The dr confirmed a corneal abrasion from a chemical burn. The supervisor was taking 3 drops of blep 3 times per day and was wearing an eye patch. She also stated that her eye was still irritated but healing. No further pt info has been rec'd.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2030538-1998-00001 |
| MDR Report Key | 147003 |
| Report Source | 05,08 |
| Date Received | 1998-01-13 |
| Date of Report | 1998-01-13 |
| Date of Event | 1997-12-05 |
| Date Mfgr Received | 1998-01-13 |
| Device Manufacturer Date | 1997-10-01 |
| Date Added to Maude | 1998-02-05 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIGNIFY STREP A TEST |
| Generic Name | QUALITATIVE TEST TO DETEST GROUP A STREP |
| Product Code | GTZ |
| Date Received | 1998-01-13 |
| Model Number | NA |
| Catalog Number | 6D95-50 |
| Lot Number | 33354M200 |
| ID Number | NA |
| Device Expiration Date | 1998-08-01 |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 143271 |
| Manufacturer | WYNTEK DIAGNOSTICS, INC. |
| Manufacturer Address | 6146 NANCY RIDGE DR. STE. 101 SAN DIEGO CA 92121 US |
| Baseline Brand Name | SIGNIFY STREP A 50 |
| Baseline Generic Name | QUALITATIVE TEST TO DETECT GROUP A STREP AG |
| Baseline Model No | NA |
| Baseline Catalog No | 6D95-50 |
| Baseline ID | * |
| Baseline Device Family | STREP A TEST |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K961423 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-01-13 |