MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-08 for MEDLINE ACCUTOUCH SYNTHETIC EXAM GLOVES REF MDS192075 manufactured by Medline.
[47216322]
Employee was potentially exposed to patient blood; she noticed blood on her finger despite using gloves. When she removed the glove, she filled it with water and noticed that water freely flowed from the fingers of the effected glove. She repeated this procedure using other gloves and the same phenomenon occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062768 |
| MDR Report Key | 5719863 |
| Date Received | 2016-06-08 |
| Date of Report | 2016-06-08 |
| Date of Event | 2016-06-07 |
| Date Added to Maude | 2016-06-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDLINE ACCUTOUCH SYNTHETIC EXAM GLOVES |
| Generic Name | ACCUTOUCH SYNTHETIC EXAM GLOVES |
| Product Code | LYZ |
| Date Received | 2016-06-08 |
| Model Number | REF MDS192075 |
| Lot Number | RB608284263 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-06-08 |