MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-09 for STERLING NITRILE POWDER-FREE EXAM GLOVES 50706 manufactured by Halyard.
[74724517]
Patient Sequence No: 1, Text Type: N, H10
[74724518]
A medical laboratory technician, in the microbiology department, removed a glove directly from the box and proceeded to put it on her hand. When her hand was inside the glove, she felt something near the end of her fingertips on her ring and pinkie finger. She removed the glove and turned it inside out. A brown, crusty residue was noticed on the inside of the glove.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6553540 |
| MDR Report Key | 6553540 |
| Date Received | 2017-05-09 |
| Date of Report | 2017-05-08 |
| Date of Event | 2017-02-21 |
| Report Date | 2017-02-24 |
| Date Reported to FDA | 2017-02-24 |
| Date Reported to Mfgr | 2017-02-24 |
| Date Added to Maude | 2017-05-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERLING NITRILE POWDER-FREE EXAM GLOVES |
| Generic Name | NITRILE POWDER-FREE EXAM GLOVES - SIZE SMALL |
| Product Code | LZC |
| Date Received | 2017-05-09 |
| Catalog Number | 50706 |
| Lot Number | SM5282ZZZ_44BX |
| ID Number | DATE OF MANUFACTURE - 10/2015 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-09 |