MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-08-22 for SAFE-SKIN SYNTHETIC POWDER FREE VINYL EXAM GLOVE * 55031 manufactured by Kimberly Clark Corporation.
[17832481]
Rn was starting iv and got blood on gloves. When the rn removed safeskin gloves, they noticed blood on fingers around nails but did not see a hole in the gloves. Rn does not have long fingernails.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 633124 |
| MDR Report Key | 633124 |
| Date Received | 2005-08-22 |
| Date of Report | 2005-08-22 |
| Date of Event | 2005-06-24 |
| Report Date | 2005-08-22 |
| Date Reported to FDA | 2005-08-22 |
| Date Added to Maude | 2005-09-07 |
| 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 | SAFE-SKIN SYNTHETIC POWDER FREE VINYL EXAM GLOVE |
| Generic Name | VINYL EXAM GLOVES |
| Product Code | LYZ |
| Date Received | 2005-08-22 |
| Model Number | * |
| Catalog Number | 55031 |
| Lot Number | SG5039952 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 622695 |
| Manufacturer | KIMBERLY CLARK CORPORATION |
| Manufacturer Address | 1400 HOLCOMB BRIDGE ROAD ROSWELL GA 30076 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-08-22 |