MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-23 for CHLORAPREP 260449 manufactured by Bd.
[45725957]
Patient Sequence No: 1, Text Type: N, H10
[45725958]
The chloraprep scratched a patient's arm when used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5671069 |
| MDR Report Key | 5671069 |
| Date Received | 2016-05-23 |
| Date of Report | 2016-03-04 |
| Date of Event | 2016-02-20 |
| Report Date | 2016-03-04 |
| Date Reported to FDA | 2016-03-04 |
| Date Reported to Mfgr | 2016-03-04 |
| Date Added to Maude | 2016-05-23 |
| 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 |
| Generic Name | DEGREASER, SKIN, SURGICAL |
| Product Code | KOY |
| Date Received | 2016-05-23 |
| Catalog Number | 260449 |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD |
| Manufacturer Address | ONE BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-23 |