MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-10-25 for MEDIGUARD * MSV512 manufactured by Medline Industries.
[15176050]
Nurse opened a new box of powder free vinyl gloves. She pulled one out and there was a red/black/orange hard lump in the bottom of the glove. It looks like a piece of burnt plastic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3441982 |
| MDR Report Key | 3441982 |
| Date Received | 2013-10-25 |
| Date of Report | 2013-10-25 |
| Date of Event | 2013-10-24 |
| Report Date | 2013-10-25 |
| Date Reported to FDA | 2013-10-25 |
| Date Reported to Mfgr | 2013-11-01 |
| Date Added to Maude | 2013-11-01 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDIGUARD |
| Generic Name | POWDERED SYNTHETIC/NON-LATEX |
| Product Code | OPG |
| Date Received | 2013-10-25 |
| Model Number | * |
| Catalog Number | MSV512 |
| Lot Number | SBS306615871 |
| ID Number | * |
| Device Availability | Y |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | ONE MEDLINE PL MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-25 |