MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-09-14 for TIGRIS INSTRUMENT SYS-CD 105118 manufactured by Hologic Incorporated.
[86150773]
(b)(4) (customer) reported that (b)(6) (operator) scratched her right hand middle finger near the knuckle. The scratch occurred when the operator was replacing the waste bag on the tigris; her hand was between the waste tubing and deflector. According to the operator, this was the first time she had replaced the waste bag after a new extended input queue (iq) was installed. The input drawer was different and she scratched her hand when pulling the waste bin out. The operator stated that she was wearing personal protective equipment (ppe) at that time. Her gloves that got torn due to the scratch. She washed her hands and applied antibacterial ointment on the scratch. A field application specialist (fas) will go onsite to retrain operators on the proper way to replace the waste bag with the new extended iq.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2017-00025 |
| MDR Report Key | 6865438 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-09-14 |
| Date of Report | 2017-09-14 |
| Date of Event | 2017-09-01 |
| Date Mfgr Received | 2017-09-01 |
| Date Added to Maude | 2017-09-14 |
| 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 | MONICA SHOON |
| Manufacturer Street | 10210 GENETIC CENTER DRIVE |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108892 |
| 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 | 3 |
| Brand Name | TIGRIS INSTRUMENT SYS-CD |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | MKZ |
| Date Received | 2017-09-14 |
| Catalog Number | 105118 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC INCORPORATED |
| Manufacturer Address | 10210 GENETIC CENTER DRIVE SAN DIEGO SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-14 |