MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-07 for ULTRASOUND GEL SS4-140A manufactured by E-z Em Co..
[7870]
Severe contact dermatitis on abdomen occurred wherever gel and transducer touched pt. Improved with steroids.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000230 |
| MDR Report Key | 11558 |
| Date Received | 1994-02-07 |
| Date of Report | 1993-03-23 |
| Date of Event | 1992-11-09 |
| Date Added to Maude | 1994-02-18 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRASOUND GEL |
| Product Code | KNG |
| Date Received | 1994-02-07 |
| Model Number | SS4-140A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11558 |
| Manufacturer | E-Z EM CO. |
| Manufacturer Address | WESTBURY NY 11590 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-02-07 |