MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-05 for TIGRIS SYSTEM 105118 manufactured by Hologic, Inc..
[74589543]
One of the laboratory technicians at the (b)(6) medical center clinical micro lab, ms. (b)(6), developed a hyper-sensitivity over 4 years ago to bleach used to clean the tigris instrument. Over time, the impact of bleach has progressively affected her health, causing ms. (b)(6) eye lids to swell shut. On (b)(6) 2017, ms. (b)(6) went to their employee health center for medical treatment. She was examined by a nurse practitioner who recommended her to avoid bleach and to wear a powered air purifying respirator (papr). (b)(4) fse visited the customer site and verified the lab is using correct volumes to make the final correct bleach dilutions. Based on a request by the customer, (b)(4) recommended the use of the bleach enhancer instead of bleach. (b)(4) fse went over the bleach enhancer pi with the lab supervisor (amy crimson) and worked with other staff to determine the volumes needed to make the least concentrated bleach per package insert instructions. One change to customer's practice is to make and discard bleach when the ms. (b)(6) (employee with the sensitivity) has left the lab for the day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2017-00013 |
| MDR Report Key | 6549609 |
| Date Received | 2017-05-05 |
| Date of Report | 2017-05-05 |
| Date of Event | 2017-04-07 |
| Date Mfgr Received | 2017-04-07 |
| Date Added to Maude | 2017-05-05 |
| 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 Contact | MS. JULIETTE BUSSE |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108799 |
| Manufacturer G1 | HOLOGIC, INC. |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TIGRIS SYSTEM |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | MKZ |
| Date Received | 2017-05-05 |
| Catalog Number | 105118 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 10210 GENETIC CENTER DRIVE SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-05 |