MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-01 for * manufactured by Wescor, Inc..
[18127414]
While tech was performing a sweat test on patient's leg, gel disk cracked and patient received a small burn 2cmx2cm area. Pt started to cry, tech checked site and noticed this, stopped testing, applied a&d ointment and notified rn, which in turn notified physician. They ordered bacitracin, then ordered silvadene bid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2192411 |
| MDR Report Key | 2192411 |
| Date Received | 2011-08-01 |
| Date of Report | 2011-08-01 |
| Date of Event | 2011-07-19 |
| Report Date | 2011-08-01 |
| Date Reported to FDA | 2011-08-01 |
| Date Added to Maude | 2011-08-05 |
| 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 | * |
| Generic Name | GEL DISC FOR SWEAT TEST |
| Product Code | KTB |
| Date Received | 2011-08-01 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 200561 |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WESCOR, INC. |
| Manufacturer Address | 370 WEST 1700 SOUTH LOGAN UT 84321 US 84321 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-01 |