MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-03-21 for MEDLINE UNIVERSAL 3G MDS196075 * manufactured by Medline Industries, Inc..
[18223781]
Icu rn reports noticing holes in one index finger and right thumb of gloves when removing. Pt had hepatitis-c and gi bleed. This has been occurring quite often. All involved rn's have stated they keep their fingernails short.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 838515 |
| MDR Report Key | 838515 |
| Date Received | 2007-03-21 |
| Date of Report | 2007-03-21 |
| Date of Event | 2007-03-19 |
| Report Date | 2007-03-21 |
| Date Reported to FDA | 2007-03-21 |
| Date Added to Maude | 2007-04-19 |
| 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 | 0 |
| 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 | MEDLINE UNIVERSAL 3G |
| Generic Name | GLOVE, EXAM, VINYL |
| Product Code | LYZ |
| Date Received | 2007-03-21 |
| Model Number | MDS196075 |
| Catalog Number | * |
| Lot Number | MA602928676 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 825818 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | 1170 NORTHPOINT BLVD WAUKEGAN IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-03-21 |