MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-02-01 for PARKER AQUASONIC GEL * manufactured by Parker Laboratories, Inc..
[142989]
Pt was in for an ultrasound of the breast. Within 24 hrs she had a rash all over her breast.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1015586 |
| MDR Report Key | 208599 |
| Date Received | 1999-02-01 |
| Date Added to Maude | 1999-02-05 |
| 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 | PARKER AQUASONIC GEL |
| Generic Name | ULTRASOUND GEL |
| Product Code | MUI |
| Date Received | 1999-02-01 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | H-128 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 202468 |
| Manufacturer | PARKER LABORATORIES, INC. |
| Manufacturer Address | 286 ELDRIDGE RD. FAIRFIELD NJ 07003 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-02-01 |