MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-15 for MEDICHOICE'S POWDER FREE STRETCH VINYL GLOVES * 1773GLV4002 manufactured by Shijiazhuang Eversharp Plastic Products Co., Ltd..
[647564]
"event desc: the stretch vinyl gloves are known for easily tearing and/or ripping. The clinician had on two pairs of gloves and noted after pt 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 gloves setup for extra precaution due to a pt 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 hands and fingers. Device usage problem: device malfunction - that is, the device did not do what it was supposed".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1451040-2007-00001 |
| MDR Report Key | 874400 |
| Date Received | 2007-06-15 |
| Date of Report | 2007-06-15 |
| Date of Event | 2007-03-14 |
| Date Facility Aware | 2007-05-18 |
| Report Date | 2007-06-15 |
| Date Reported to FDA | 2007-06-15 |
| Date Reported to Mfgr | 2007-06-15 |
| Date Added to Maude | 2007-07-05 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | BIOMEDICAL ENGINEER |
| 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 | 2007-06-15 |
| Model Number | * |
| Catalog Number | 1773GLV4002 |
| Lot Number | CSHG01-30 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 854297 |
| Manufacturer | SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD. |
| Manufacturer Address | NO. 312 E LONG QUAN RD. LUQUAN, HEBEI PROVINCE CH 050000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-15 |