MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-21 for CENTRAL LINE DRESSING CHANGE KIT * 2883 manufactured by Lsl Industries Inc..
[2884819]
Central line dressing change tray was opened and found to contain only one sterile glove. According to the label, a pair of sterile gloves should have been included. This is the second time we have had an item missing from this manufacturer's kit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2766903 |
| MDR Report Key | 2766903 |
| Date Received | 2012-09-21 |
| Date of Report | 2012-09-21 |
| Date of Event | 2012-09-12 |
| Report Date | 2012-09-21 |
| Date Reported to FDA | 2012-09-21 |
| Date Added to Maude | 2012-10-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 | CENTRAL LINE DRESSING CHANGE KIT |
| Generic Name | KIT, WOUND DRESSING |
| Product Code | MCY |
| Date Received | 2012-09-21 |
| Model Number | * |
| Catalog Number | 2883 |
| Lot Number | 2E3148 |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LSL INDUSTRIES INC. |
| Manufacturer Address | 5535 N. WOLCOTT AVE. CHICAGO IL 60640 US 60640 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-21 |