MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-11-26 for ULTRIO PLUS 302573 manufactured by Hologic Incorporated.
[5294115]
A (b)(6) operator in (b)(6) was injured on the right hand with a tip during the emptying of a tigris waste (diti bag) bag. The operator disinfected the injury and visited the on-site doctor who gave her a post exposure prophylaxis. The operator, 10 days after the incident, did all the tests required to verify a possible infection; so far, everything resulted negative.
Patient Sequence No: 1, Text Type: D, B5
[12584100]
The event occurred while the operator was removing waste bags from the tigris instrument after running ultrio plus assays ((b)(4)). Although the performance of the assay is not in question, hologic is investigating the occurrence further to determine if there is something the operator did that contributed to the event and/or if the waste bags somehow contributed to the event. Additional information will be provided when available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024800-2014-00005 |
| MDR Report Key | 4281158 |
| Report Source | 07 |
| Date Received | 2014-11-26 |
| Date of Report | 2014-11-25 |
| Date of Event | 2014-10-19 |
| Date Mfgr Received | 2014-11-03 |
| Date Added to Maude | 2014-11-26 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RON DOMINGO |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108167 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRIO PLUS |
| Generic Name | IN VITRO DIAGNOSTIC ASSAY |
| Product Code | LSL |
| Date Received | 2014-11-26 |
| Catalog Number | 302573 |
| Lot Number | ML 635124 |
| ID Number | ML 636815 |
| Device Expiration Date | 2015-09-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC INCORPORATED |
| Manufacturer Address | 10210 GENETIC CENTER DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-11-26 |