MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-04-08 for FARRALL INSTRUMENTS SWEAT CHLORIDE POTENTIOMETER IPS-25-A NONE manufactured by Farrall Instruments.
[50005]
During sweat chloride procedure, the negative electrode left a small burn on pt's arm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011111 |
| MDR Report Key | 82081 |
| Date Received | 1997-04-08 |
| Date of Report | 1997-03-31 |
| Date of Event | 1997-03-19 |
| Date Added to Maude | 1997-04-10 |
| 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 | RISK MANAGER |
| 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 | FARRALL INSTRUMENTS SWEAT CHLORIDE POTENTIOMETER |
| Generic Name | SWEAT CHLORIDE POTENTIOMETER |
| Product Code | KTB |
| Date Received | 1997-04-08 |
| Model Number | IPS-25-A |
| Catalog Number | NONE |
| Lot Number | NONE |
| ID Number | NONE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 81484 |
| Manufacturer | FARRALL INSTRUMENTS |
| Manufacturer Address | 3724 ARCH AVE GRAND ISLAND NE 68803 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 1997-04-08 |