MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-02-26 for SURECELL CHLAMYDIA TEST KIT 1937804 manufactured by Johnson & Johnson Clinical Diagnostics.
[48195]
Operator at a veterinary hosp splashed the chlamydia test kit extraction tube solution into eyes. Operator irrigated both eyes and sought medical attention. Operator was treated by flushing eyes and prescribed antibiotics. Exam of eyes concluded no injury to cornea. Sample in extraction tube tested negative for chlamydia. Operator was sent home. Operator contacted on 2/7 to follow up on status. He indicated that he is doing fine and not experiencing any complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319520-1997-00003 |
| MDR Report Key | 73242 |
| Report Source | 05 |
| Date Received | 1997-02-26 |
| Date of Report | 1997-01-27 |
| Date of Event | 1997-01-27 |
| Date Mfgr Received | 1997-01-27 |
| Device Manufacturer Date | 1995-10-01 |
| Date Added to Maude | 1997-03-06 |
| 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 |
| Reporter Occupation | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURECELL CHLAMYDIA TEST KIT |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | LSK |
| Date Received | 1997-02-26 |
| Model Number | NA |
| Catalog Number | 1937804 |
| Lot Number | CHT09919 |
| ID Number | NA |
| Device Expiration Date | 1996-11-30 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 73079 |
| Manufacturer | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 14650 US |
| Baseline Brand Name | SURECELL CHLAMYDIA TEST KIT |
| Baseline Generic Name | IN VITRO DIAGNOSTIC (CHLAMYDIA) |
| Baseline Model No | NA |
| Baseline Catalog No | 1937804 |
| Baseline ID | NA |
| Baseline Device Family | SURECELL CHLAMYDIA TEST KIT |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 13 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K900402 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-02-26 |