MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-19 for ULTRASOUND GEL manufactured by .
[18047410]
Pt called to report that she has had a rash on her stomach, knees, thighs and arm three times a week and was diagnosed with pseudomonas. Pt was prescribed antibiotic which is currently working. Pt originally thought she contracted rash from local lake that was shutdown due to animals dying because she went fishing, but she is 32 weeks pregnant and has baby heart rate checked every visit using ultra sound gel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025084 |
| MDR Report Key | 2543183 |
| Date Received | 2012-04-19 |
| Date of Report | 2012-04-19 |
| Date of Event | 2012-03-01 |
| Date Added to Maude | 2012-04-23 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | ULTRASOUND GEL |
| Product Code | GYB |
| Date Received | 2012-04-19 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-19 |