MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2006-03-06 for MACRODUCT SWEAT COLLECTION SYSTEM 3700 3700-SYSTEM manufactured by Wescor, Inc..
[450264]
A male underwent a sweat test to test for cystic fibrosis. About 2 minutes into the pilocarpine iontophoresis procedure to induce sweat, the patient became agitated and indicated pain specifically under the positive electrode. The test was discontinued, the electrode was removed and there was a black dot (1-2mm) which was verified by a physician as a burn. The pilogel disc was examined and appeared to be intact. The test was immediately repeated without incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717966-2006-00001 |
| MDR Report Key | 691621 |
| Report Source | 00,05 |
| Date Received | 2006-03-06 |
| Date of Report | 2006-02-24 |
| Date of Event | 2005-12-20 |
| Date Mfgr Received | 2006-01-10 |
| Device Manufacturer Date | 1994-10-01 |
| Date Added to Maude | 2006-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 459 SOUTH MAIN STREET |
| Manufacturer City | LOGAN UT 84321 |
| Manufacturer Country | US |
| Manufacturer Postal | 84321 |
| Manufacturer Phone | 4357526011 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MACRODUCT SWEAT COLLECTION SYSTEM |
| Generic Name | SWEAT INDUCING DEVICE BY IONTOPHORESIS |
| Product Code | KTB |
| Date Received | 2006-03-06 |
| Returned To Mfg | 2006-02-22 |
| Model Number | 3700 |
| Catalog Number | 3700-SYSTEM |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 680757 |
| Manufacturer | WESCOR, INC. |
| Manufacturer Address | * LOGAN UT 84321 US |
| Baseline Brand Name | MACRODUCT SWEAT COLLECTION SYSTEM |
| Baseline Generic Name | SWEAT INDUCING DEVICE BY IONTOPHORESIS |
| Baseline Model No | 3700 |
| Baseline Catalog No | 3700-SYSTEM |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-03-06 |