MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-09-27 for TESTPACK CHLAMYDIA 3436-18 manufactured by Abbott Laboratories.
[19140060]
Account states that a nursing services coordinator was splattered with an endocervical sample which was mixed with reagent a & b of the chlamydia test pack. Reagent a & b were added to sample along with the filtration device. When the device cap was opened, the sample mixture splattered in the eyes and mouth and on the face of the coordinator performing the assay. The account states there was resistance and pressure built up as the plunger was pushed into the sample. When the lid of the plunger was opened, the material splattered because of being under pressure. The coordinator was not wearing goggles at the time of the event. The nursing coordinator has gone through the clinic's exposure control plan, has been treated with antibiotics, and will receive the hepatitis vaccine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1451914-1996-00002 |
| MDR Report Key | 55975 |
| Report Source | 05 |
| Date Received | 1996-09-27 |
| Date of Report | 1996-09-27 |
| Date of Event | 1996-08-29 |
| Date Mfgr Received | 1996-08-29 |
| Device Manufacturer Date | 1996-04-01 |
| Date Added to Maude | 1996-12-18 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TESTPACK CHLAMYDIA |
| Generic Name | RAPID IMMUNOASSAY FOR CHLAMYDIA |
| Product Code | LSK |
| Date Received | 1996-09-27 |
| Model Number | NA |
| Catalog Number | 3436-18 |
| Lot Number | 16617M301 |
| ID Number | NI |
| Device Expiration Date | 1996-10-21 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 56504 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | INTERSECTION US 41 & 22ND ST NORTH CHICAGO IL 60064 US |
| Baseline Brand Name | NESTPACK CHLAMYDIA |
| Baseline Generic Name | RAPID IMMUNOASSAY FOR CHLAMYDIA |
| Baseline Model No | NA |
| Baseline Catalog No | 3436-18 |
| Baseline ID | NA |
| Baseline Device Family | TESTPACK CHLAMYDIA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 7 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K880783 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-09-27 |