MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for HILL IFC manufactured by Hill Ifc.
[184639258]
Pt went to er after therapy treatment at our office to right shoulder for burn injury. Pt treated and released. Device taken out of treatment area not in. Not as of (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9829647 |
| MDR Report Key | 9829647 |
| Date Received | 2020-03-12 |
| Date of Report | 2019-11-06 |
| Date of Event | 2019-12-15 |
| Date Facility Aware | 2019-01-06 |
| Report Date | 2019-01-06 |
| Date Reported to FDA | 2019-01-10 |
| Date Reported to Mfgr | 2019-01-10 |
| Date Added to Maude | 2020-03-13 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | HILL IFC |
| Generic Name | HILL IFC |
| Product Code | GZJ |
| Date Received | 2020-03-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 14 DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL IFC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-12 |