MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-03 for CHLORAPREP 260815 manufactured by Carefusion.
[69340750]
Pt was prepped around incision site. Allergic reaction to chloraprep used in surgery case. Reported to surgeon 4 days post op. Rash and blisters around incision and steristrips. At 4 days post op pt reported rash and blisters around incision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068290 |
| MDR Report Key | 6383448 |
| Date Received | 2017-03-03 |
| Date of Report | 2017-02-02 |
| Date of Event | 2016-12-12 |
| Date Added to Maude | 2017-03-07 |
| 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 |
| 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 | CHLORAPREP |
| Generic Name | CHLORAPREP |
| Product Code | KXF |
| Date Received | 2017-03-03 |
| Model Number | 260815 |
| Catalog Number | 260815 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | EL PASO TX 79912 US 79912 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-03 |