MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-09 for IONTOPHORESIS SWEAT CHLORIDE GIBSON COOKE SWEAT TEST APPARAT * manufactured by Farrall Instruments.
[569086]
Patient undergoing sweat testing (iontophoresis - sweat chloride. ) right arm tested without difficulty. During test of left arm, child began to cry. When the electrode was removed, the arm appeared to be burned with black pinhole marks and welts on arm under electrode area and out from around electrodes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 813719 |
| MDR Report Key | 813719 |
| Date Received | 2007-01-09 |
| Date of Report | 2007-01-09 |
| Date of Event | 2006-12-01 |
| Report Date | 2007-01-09 |
| Date Reported to FDA | 2007-01-09 |
| Date Added to Maude | 2007-02-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IONTOPHORESIS SWEAT CHLORIDE GIBSON COOKE SWEAT TEST APPARAT |
| Generic Name | SENSOR, SWEAT TESTER |
| Product Code | KTB |
| Date Received | 2007-01-09 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 801208 |
| Manufacturer | FARRALL INSTRUMENTS |
| Manufacturer Address | 3724 ARCH AVE. GRAND ISLAND NE 68803 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-09 |