MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-19 for DRESSING CHANGE TRAY W/CHG MSDC-10956 manufactured by Medstream.
[2753783]
Pt has developed a mild rash on his skin where a dressing kit (supplied by (b)(6)), prod #; (b)(4), lot # 2011060 was applied to protect the pt's picc access site. Dates of use: (b)(6) 2012. Event abated after use stopped: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025157 |
| MDR Report Key | 2547872 |
| Date Received | 2012-04-19 |
| Date of Report | 2012-04-19 |
| Date of Event | 2012-04-12 |
| Date Added to Maude | 2012-04-26 |
| 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 | 0 |
| Reporter Occupation | PHARMACIST |
| 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 | DRESSING CHANGE TRAY W/CHG |
| Generic Name | DRESSING CHANGE TRAY W/CHG |
| Product Code | MCY |
| Date Received | 2012-04-19 |
| Catalog Number | MSDC-10956 |
| Lot Number | 201107 |
| Device Expiration Date | 2013-07-31 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDSTREAM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-19 |