MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-27 for CADEXOMER IODINE manufactured by Unk.
[69252760]
Patient developed diffuse rash on chest, abdomen, arms, back, and mid thighs. No other symptoms observed during hospital admission for right foot lesion. Pt was receiving several medications, including antibiotics, which may have also contributed to the hypersensitivity reaction. Cadexomer iodine as well as vancomycin and zosyn were discontinued upon observation of the rash. Patient received a dose of diphenhydramine. Rash gradually improved over the next 2-3 days. Symptoms: rash. Dates of use: (b)(6) 2016 thru (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068258 |
| MDR Report Key | 6380040 |
| Date Received | 2017-02-27 |
| Date of Report | 2017-02-19 |
| Date of Event | 2017-01-04 |
| Date Added to Maude | 2017-03-06 |
| 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 | PHARMACIST |
| 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 | 0 |
| Brand Name | CADEXOMER IODINE |
| Generic Name | IODOSORB |
| Product Code | KOZ |
| Date Received | 2017-02-27 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-27 |