MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-11 for MEDICHOICE'S POWDER-FREE STRETCH VINYL GLOVES UNK * manufactured by Owens And Minor, Inc..
[558151]
The stretch vinyl gloves are known for easily tearing and/or ripping. The clinician had on two pairs of gloves and noted after patient care, which included handling bloody dressings etc. , that blood was found on the under layer of the gloves even though there were no obvious tears or rips noted. A similar incident occurred with another clinician who also had used a double gloved setup for extra precaution due to a patient with severe gi bleed. Clinician noted that blood had seeped through to the under layer of the gloves. The clinician removed this glove, washed hands, dried them, and put on a double layer again. The same failure happened again, except this time the blood had seeped onto the hand and fingers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 839554 |
| MDR Report Key | 839554 |
| Date Received | 2007-04-11 |
| Date of Report | 2007-04-11 |
| Date of Event | 2007-03-14 |
| Report Date | 2007-04-11 |
| Date Reported to FDA | 2007-04-11 |
| Date Added to Maude | 2007-04-23 |
| 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 | MEDICHOICE'S POWDER-FREE STRETCH VINYL GLOVES |
| Generic Name | GLOVES, PROTECTION |
| Product Code | LYZ |
| Date Received | 2007-04-11 |
| Model Number | UNK |
| Catalog Number | * |
| Lot Number | CSHG01-30 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 826842 |
| Manufacturer | OWENS AND MINOR, INC. |
| Manufacturer Address | 4800 COAX ROAD GLEN ALLEN VA 230606292 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-11 |