MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-12 for CHLORAPREP/CHLORAHEXIDINE manufactured by Unknown.
[35619279]
Patient Sequence No: 1, Text Type: N, H10
[35619280]
Post-operative patient was found to have discoloration with small blisters to bilateral buttocks. Chloraprep was used to prep surgical site. During surgery, the patient was placed on k-thermia warming device (38 degrees celsius) with three layers between patient and k-thermia pad. Patient secured to table with 2 inch tape.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5359693 |
| MDR Report Key | 5359693 |
| Date Received | 2016-01-12 |
| Date of Report | 2015-12-23 |
| Date of Event | 2015-10-22 |
| Report Date | 2015-12-17 |
| Date Reported to FDA | 2015-12-17 |
| Date Reported to Mfgr | 2015-12-17 |
| Date Added to Maude | 2016-01-12 |
| 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 | CHLORAPREP/CHLORAHEXIDINE |
| Generic Name | DISINFECTANT, SKIN PREP |
| Product Code | KOY |
| Date Received | 2016-01-12 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-12 |