MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-22 for HALYARD CRI-17-50-04 manufactured by Halyard Health, Inc..
[176773194]
Pt received a burn to her left knee when the introducer was being removed during knee rhizotomy procedure. Pt was referred to the wound center for evaluation and treatment. Upon inspection of the introducer probe, there appeared to be an area near the hub that was not appropriately insulated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9638909 |
| MDR Report Key | 9638909 |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-20 |
| Date of Event | 2020-01-16 |
| Date Facility Aware | 2020-01-16 |
| Report Date | 2020-01-20 |
| Date Reported to FDA | 2020-01-20 |
| Date Reported to Mfgr | 2020-01-20 |
| Date Added to Maude | 2020-01-28 |
| 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 | HALYARD |
| Generic Name | COOLIEF COOLED RADIOFREQUENCY INTRODUCER |
| Product Code | GXI |
| Date Received | 2020-01-22 |
| Catalog Number | CRI-17-50-04 |
| Lot Number | M19185D208 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH, INC. |
| Manufacturer Address | 5405 WINDWARD PKWY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-22 |