MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-08 for DRESSING CHANGE TRAY DT5565B manufactured by Centurion Medical Products Corporation.
[25112478]
Patient Sequence No: 1, Text Type: N, H10
[25112479]
Nurse stated: "today i removed a dressing from a central line. The skin was very irritated around the edge of the dressing where the white tape is. It almost appears burned. In addition [patient] has an area that was actually ripped open from the previous dressing. " nurse also noted that two other patient with that dressing had experienced similar irritation at the dressing site; those patients were being treated at a neighboring cancer center but had had ports inserted at our hospital. Both of those patients are females in their 50's and being treated for breast cancer. [one of the cancer center patients is a relative of the nurse making the report. ] manufacturer response for cvc dressing change tray, centurion cvc dressing change tray (per site reporter): awaiting call back from manufacturer's representative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5060165 |
| MDR Report Key | 5060165 |
| Date Received | 2015-09-08 |
| Date of Report | 2015-08-24 |
| Date of Event | 2015-08-24 |
| Report Date | 2015-08-24 |
| Date Reported to FDA | 2015-08-24 |
| Date Reported to Mfgr | 2015-08-24 |
| Date Added to Maude | 2015-09-08 |
| 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 | DRESSING CHANGE TRAY |
| Generic Name | DRESSING CHANGE TRAY |
| Product Code | MCY |
| Date Received | 2015-09-08 |
| Catalog Number | DT5565B |
| Lot Number | 2015042790 |
| Device Expiration Date | 2017-12-01 |
| Operator | NURSE |
| Device Availability | N |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CENTURION MEDICAL PRODUCTS CORPORATION |
| Manufacturer Address | 100 CENTURION WAY WILLIAMSTON MI 48895 US 48895 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-08 |