MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-11-17 for BOX OF COLL KITS,VAGINAL SWAB (IVD) 50PK 301162 manufactured by Hologic, Inc.
[92357291]
(b)(6) (customer) reported that (b)(6) (nurse) at their site inadvertently splashed some transfer solution into an eye while breaking a vaginal swab in the tube. The swab with the specimen was already in solution. The nurse immediately flushed the affected eye with water per the instructions provided in the safety data sheet. In addition, (b)(6) flushed (b)(6) eye using a 10 cc syringe with sterile water. Per osha guidelines, a 'general accidental chemical exposure incident report' form was filled out. No professional medical treatment was sought as the affected individual had not complained about any further medical issues regarding this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2017-00026 |
| MDR Report Key | 7041805 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-11-17 |
| Date of Report | 2017-11-17 |
| Date of Event | 2017-10-24 |
| Date Mfgr Received | 2017-10-24 |
| Date Added to Maude | 2017-11-17 |
| 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 DR. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108799 |
| Manufacturer G1 | HOLOGIC, INC. |
| Manufacturer Street | 10210 GENETIC CENTER DR. |
| 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 | BOX OF COLL KITS,VAGINAL SWAB (IVD) 50PK |
| Generic Name | IN-VITRO DIAGNOSTIC, PRODUCT CODE |
| Product Code | LIO |
| Date Received | 2017-11-17 |
| Catalog Number | 301162 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 10210 GENETIC CENTER DR. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-17 |