MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-15 for FLEXAL NITRILE 88TN04L manufactured by Cardinal Health 200, Llc.
[62442524]
Patient Sequence No: 1, Text Type: N, H10
[62442525]
There have been numerous occasions where the exams gloves used (flexal nitrile) have been breaking during their cleaning of the operating rooms post surgical. Since the technicians are cleaning the rooms and moving equipment, the workers are exposed to blood and other fluids in the event the glove tears while performing this task.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6175521 |
| MDR Report Key | 6175521 |
| Date Received | 2016-12-15 |
| Date of Report | 2016-10-26 |
| Date of Event | 2016-10-18 |
| Report Date | 2016-10-26 |
| Date Reported to FDA | 2016-10-26 |
| Date Reported to Mfgr | 2016-10-26 |
| Date Added to Maude | 2016-12-15 |
| 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 | 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 | FLEXAL NITRILE |
| Generic Name | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE |
| Product Code | LZA |
| Date Received | 2016-12-15 |
| Model Number | 88TN04L |
| Catalog Number | 88TN04L |
| Lot Number | 5D16H070 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 1500 WAUKEGAN RD. WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-15 |