MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-19 for CARDINAL HEALTH ULTRASOUND GEL USG250BT manufactured by Covidien.
[139421002]
Had ultrasounds on (b)(6) and (b)(6) "2018", which resulted in rashes which spread over entire body - ultrasound gel product was cardinal health ultrasound gel. Have been treated with fluocinonide cream, desoximetasone cream, oral prednisone (all steroids) and tacrolimus ointment. Rash still persists and keeps spreading. Persistent painful, raw itchy rash resulted from product. Distributed by (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085017 |
| MDR Report Key | 8436315 |
| Date Received | 2019-03-19 |
| Date of Report | 2019-03-06 |
| Date of Event | 2018-09-28 |
| Date Added to Maude | 2019-03-20 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | CARDINAL HEALTH ULTRASOUND GEL |
| Generic Name | MEDIA COUPLING ULTRASOUND |
| Product Code | MUI |
| Date Received | 2019-03-19 |
| Catalog Number | USG250BT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-03-19 |