MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-08-30 for CHLORAPREP ONE STEP * 260700 manufactured by Enturia Inc..
[724766]
Patient was undergoing a temporal artery biopsy. The patient was prepped with chloraprep one step and then draped appropriately. The operative site was then reprepped with additional skin prep (chloraprep one step). The procedure was begun, an incision was made and the electrocautery unit was applied at which time a flame occurred and was immediately extinguished. The patient experienced first degree burns on both ears as well as one spot of second degree burn on the neckline that only required topical treatment. The patient was discharged the following day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 916653 |
| MDR Report Key | 916653 |
| Date Received | 2007-08-30 |
| Date of Report | 2007-08-29 |
| Date of Event | 2007-06-19 |
| Report Date | 2007-08-29 |
| Date Reported to FDA | 2007-08-30 |
| Date Added to Maude | 2007-09-24 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHLORAPREP ONE STEP |
| Generic Name | SURGICAL PREP, SOLUTION |
| Product Code | KOY |
| Date Received | 2007-08-30 |
| Model Number | * |
| Catalog Number | 260700 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 889734 |
| Manufacturer | ENTURIA INC. |
| Manufacturer Address | 11400 TOMAHAWK CREEK PKWY SUITE 310 LEAWOOD KS 66211 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-30 |