MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-09-07 for ABBOTT HTLV-I/HTLV-II EIA 7A92-31 manufactured by Abbott Laboratories.
[434910]
The operator received a tetanus shot after being splashed with htlv-i/ii positive control. The htlv-i/ii positive control was in a glass tube instead of the plastic control vial that is packaged in. The glass tube broke in the operator's hand and tore through the operator's glove. The operator was unsure if any htlv-i/ii positive control was splashed into the cut on their hand. The operator cleaned the cut and received a tatanus shot. The operator was previously vaccinated for hepatitis b. A baseline serum sample was obtained from the operator and another serum sample will be obtained in 3 to 6 months. No serious injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2005-00025 |
| MDR Report Key | 633374 |
| Report Source | 06 |
| Date Received | 2005-09-07 |
| Date of Report | 2005-09-06 |
| Date Mfgr Received | 2005-08-12 |
| Date Added to Maude | 2005-09-08 |
| 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 | 0 |
| Manufacturer Contact | DR. DAVID BARCH D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT HTLV-I/HTLV-II EIA |
| Generic Name | EIA DETECTION OF HTLV-I/HTLV-II ANTIBODIES |
| Product Code | LRM |
| Date Received | 2005-09-07 |
| Model Number | NA |
| Catalog Number | 7A92-31 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 622943 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US |
| Baseline Brand Name | HTLV I/II EIA W/A 1000 TEST KIT |
| Baseline Generic Name | EIA FOR DETECTION OF HTLV-I/ HTLV-II ANTIBODIES |
| Baseline Model No | NA |
| Baseline Catalog No | 7A92-31 |
| Baseline ID | NA |
| Baseline Device Family | ABBOTT HTLV I/II EIA |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-09-07 |