MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-04-23 for TRINITY BIOTECH UNIGOLD RECOMBIGEN HIV CNT 1206530 manufactured by Trinity Biotech Plc,.
[842722]
In 2008, trinity biotech (trinity) technical services received a phone call from the supervising nurse of face to face's safe zone. They had an exposure incident involving a laboratory technologist performing testing with the trinity biotech unigold recombigen positive control. Face to face's safe zone is located at 1 support face to face. The technologist was handling the positive control (kit lot no. R065001, positive control lot no. R05108) without wearing gloves and some of the fluid splashed on his right hand (fingertip). The technologist felt a ''burning sensation" and rinsed with water, then used an alcohol wipe. It was noted there were no open sores or cuts on his hand. The meds sheet for the product was faxed to the site for their review. Trinity has also confirmed the positive material used to mfr the positive control has undergone chemical treatment (1 bpuv (virucidal agent) and uv-irradiation and has been certified negative after a virus culture assay. The technician was followed up by the staff nurse and a blood sample was drawn for baseline testing and will be scheduled for follow up testing to occur at 3 to 6 months.
Patient Sequence No: 1, Text Type: D, B5
[8033060]
Trinity has confirmed the positive material used to mfr the positive control has undergone chemical treatment (1 bpuv (virucidal agent) and uv-irradiation and has been certified negative after a virus culture assay, therefore, deem the exposure risk to be low. However, it should be noted the lab tech was using the product outside of the recommended safe laboratory practices, as he was not wearing gloves while handling the material.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1318354-2008-00001 |
| MDR Report Key | 1038736 |
| Report Source | 05,06 |
| Date Received | 2008-04-23 |
| Date of Report | 2008-04-23 |
| Date of Event | 2008-03-27 |
| Date Facility Aware | 2008-03-27 |
| Report Date | 2008-04-23 |
| Date Reported to FDA | 2008-04-23 |
| Date Reported to Mfgr | 2008-04-23 |
| Date Mfgr Received | 2008-03-28 |
| Device Manufacturer Date | 2007-02-01 |
| Date Added to Maude | 2009-05-05 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | IDA BUSINESS PARK |
| Manufacturer City | BRAY, CO. WICKLOW |
| Manufacturer Country | EI |
| Manufacturer Phone | 353128759 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRINITY BIOTECH UNIGOLD RECOMBIGEN HIV CNT |
| Generic Name | NONE |
| Product Code | MVW |
| Date Received | 2008-04-23 |
| Catalog Number | 1206530 |
| Lot Number | R065001 |
| ID Number | R05108 |
| Device Expiration Date | 2008-02-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 12 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRINITY BIOTECH PLC, |
| Manufacturer Address | IDA BUSINESS PARK BRAY, CO. WICKLOW EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-23 |