MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-17 for TRACHEOSTOMY CLEAN AND CARE TRAY manufactured by Medline Industries, Inc..
[21262125]
Pt being cared for at a home. When tracheostomy care kit was opened by family member, black matter was noted on a gauze dressing in the kit. The home care nurse subsequently opened another kit from the same lot number, and it also contained a gauze with black matter on it. Neither dressing was used on the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026585 |
| MDR Report Key | 2711103 |
| Date Received | 2012-08-17 |
| Date of Report | 2012-08-17 |
| Date of Event | 2012-08-09 |
| Date Added to Maude | 2012-08-24 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRACHEOSTOMY CLEAN AND CARE TRAY |
| Generic Name | NONE |
| Product Code | OGV |
| Date Received | 2012-08-17 |
| Lot Number | 12CY0032 |
| ID Number | REF# DYND40610 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PL. MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-17 |