MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-07 for CORAM BRAND CENTRAL LINE DRESSING CHANGE TRAY K-3501 manufactured by Coram.
[4322242]
Pt has lyme's diagnosed, started iv roc (b)(6) 2009. And zithromax 250mg iv every week. Pt has picc line. Nka. Developed rash on arm where picc line is 1 month after starting iv abx. Rash is from shoulder to wrist. Different central line dressings work better for him. Pt went to emergency room (b)(6) 2009 and doctor discontinued rocephin and zithromax but picc line remains.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5035486 |
| MDR Report Key | 3732579 |
| Date Received | 2014-04-07 |
| Date of Report | 2009-07-04 |
| Date of Event | 2009-07-02 |
| Date Added to Maude | 2014-04-10 |
| 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 | CORAM BRAND CENTRAL LINE DRESSING CHANGE TRAY |
| Generic Name | CENTRAL LINE DRESSING CHANGE TRAY |
| Product Code | PEZ |
| Date Received | 2014-04-07 |
| Catalog Number | K-3501 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORAM |
| Brand Name | TEGADERM |
| Generic Name | DRESSING |
| Product Code | FRO |
| Date Received | 2014-04-07 |
| Catalog Number | K-3501 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-07 |