MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-10-19 for WEBSTER SWEAT INDUCER 3700 * manufactured by Wescor Inc..
[21380480]
Chloride sweat test done and after the exam three circular second degree burns were noted on patient's arm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 644998 |
| MDR Report Key | 644998 |
| Date Received | 2005-10-19 |
| Date of Report | 2005-10-19 |
| Date of Event | 2005-09-06 |
| Report Date | 2005-10-19 |
| Date Reported to FDA | 2005-10-19 |
| Date Added to Maude | 2005-11-09 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | WEBSTER SWEAT INDUCER |
| Generic Name | CHLORIDE SWEAT TESTING DEVICE |
| Product Code | KTB |
| Date Received | 2005-10-19 |
| Returned To Mfg | 2005-09-16 |
| Model Number | 3700 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 634488 |
| Manufacturer | WESCOR INC. |
| Manufacturer Address | 459 SOUTH MAIN STREET LOGAN UT 84321 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-10-19 |