MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-02-03 for MACRODUCT SYSTEM (SWEAT CHLORIDE TEST/ PILOGEL DISCS) * SS-023 manufactured by Wescor, Inc..
[1011004]
An infant patient underwent sweat a chloride test to right arm per lab technician. Pt started to cry during five minute test. Rn removed band and electrodes from right arm. The right hand was bluish in color until immediatelty after band released. A half dollar size area of redness was noted on right anterior forearm with four small pinpoint areas of brownish blue skin. Indentation was noted to right wrist from black band. Pediatrician notified. The affected area was immediately cleansed with sterile water. Neosporin applied and then dressed with kerlix gauze dressing. ====================== manufacturer response for sweat chloride test/ pilogel discs, wescor macroduct system======================i talked with mfr who will be sending a loaner unit. He also recommended a parent education sheet which is included in a supply kit. Several follow-up and user questions were discussed. I will follow-up with the company who seems very interested in patient well being and patient safety
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1311849 |
| MDR Report Key | 1311849 |
| Date Received | 2009-02-03 |
| Date of Report | 2009-02-03 |
| Date of Event | 2009-02-02 |
| Report Date | 2009-02-03 |
| Date Reported to FDA | 2009-02-03 |
| Date Added to Maude | 2009-02-17 |
| 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 | MACRODUCT SYSTEM (SWEAT CHLORIDE TEST/ PILOGEL DISCS) |
| Generic Name | DEVICE, IONTOPHORESIS |
| Product Code | KTB |
| Date Received | 2009-02-03 |
| Model Number | * |
| Catalog Number | SS-023 |
| Lot Number | 100754 |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 16 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WESCOR, INC. |
| Manufacturer Address | 459 SOUTH MAIN STREET LOGAN UT 84321 US 84321 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-03 |