MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-28 for MCKESSON NITRILE EXAM GLOVES POWDER FREE MFR 14-656C manufactured by Mckesson.
[74303932]
A pharmacy tech obtained a pair of nitrile gloves to use while cleaning and noticed a brownish/reddish color/stain splattered on them. The discoloration was consistent throughout the entire box of gloves. No harm or injury to the staff member. The gloves are ordered through the pharmacy wholesaler, (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069487 |
| MDR Report Key | 6538117 |
| Date Received | 2017-04-28 |
| Date of Report | 2017-04-28 |
| Date of Event | 2017-04-12 |
| Date Added to Maude | 2017-05-02 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | MCKESSON NITRILE EXAM GLOVES POWDER FREE |
| Generic Name | GLOVES |
| Product Code | LYY |
| Date Received | 2017-04-28 |
| Model Number | MFR 14-656C |
| Lot Number | MHD11-01-M4F |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MCKESSON |
| Manufacturer Address | LOVELAND CO 80538 US 80538 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-28 |