MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-05-17 for NORCO BUTTERFLY NC89255B manufactured by Axelgaard Manufacturing Company.
[2142701]
On (b)(6) 2011, the hand therapy clinic of (b)(6) was treating their pt, (b)(6) for tendonitis using iontophoresis as a treatment. The iontophoresis delivery unit was an empi model lr64406 stimulator. The electrodes used were from iontophoresis treatment kit (b)(4), which has a butterfly shaped drug delivery electrode. The pharmaceutical administered was dexamethasone. At the conclusion of the treatment, the pt developed a circular wound about 1. 5 cm in diameter, with yellow necrotic tissue in the center, raised about 7mm. A report was taken on (b)(6) 2011, from the therapist, (b)(6) who was treating the pt. After the report was taken, the report, and the electrode that was used for the treatment was forwarded to the mfr of the electrode for analysis and conclusion on (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939821-2011-00002 |
| MDR Report Key | 2104032 |
| Report Source | 06 |
| Date Received | 2011-05-17 |
| Date of Report | 2011-05-16 |
| Date of Event | 2011-04-22 |
| Date Mfgr Received | 2011-05-12 |
| Date Added to Maude | 2011-06-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | PEGGY COLLINS, MGR |
| Manufacturer Street | 520 INDUSTRIAL WAY |
| Manufacturer City | FALLBROOK CA 92028 |
| Manufacturer Country | US |
| Manufacturer Postal | 92028 |
| Manufacturer Phone | 7604518046 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NORCO |
| Generic Name | IONTOPHORESIS ELECTRODE |
| Product Code | EGJ |
| Date Received | 2011-05-17 |
| Returned To Mfg | 2011-05-12 |
| Model Number | BUTTERFLY |
| Catalog Number | NC89255B |
| Lot Number | 65830211004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AXELGAARD MANUFACTURING COMPANY |
| Manufacturer Address | FALLBROOK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-05-17 |