MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-10-03 for BUFFERED IONTOPHORETIC DELIVERY ELECTRODE NC89251B manufactured by North Coast Medical, Inc..
[232862]
During an iontophoresis electrode treatment administered with dexamethasone, the pt received a burn on the elbow that blistered and scabbed from the active electrode. The burn was approx 1cm round in size. According to the physical therapist, the recommended treatment time of 40ma-minutes was not exceeded and the instruction for use were followed correctly. The administered drug, dexamethasone, was prescribed by the health professional and not sold with the electrode.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 355273 |
| MDR Report Key | 355273 |
| Date Received | 2001-10-03 |
| Date of Report | 2001-08-20 |
| Date of Event | 2001-08-15 |
| Date Facility Aware | 2001-08-15 |
| Report Date | 2001-08-20 |
| Date Added to Maude | 2001-10-12 |
| 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 | BUFFERED IONTOPHORETIC DELIVERY ELECTRODE |
| Generic Name | IONTOPHORESIS ELECTRODE |
| Product Code | KTB |
| Date Received | 2001-10-03 |
| Model Number | NC89251B |
| Catalog Number | NC89251B |
| Lot Number | 7031-1 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 344495 |
| Manufacturer | NORTH COAST MEDICAL, INC. |
| Manufacturer Address | 18305 SUTTER BLVD. MORGAN HILL CA 95037 US |
| Baseline Brand Name | BUFFERED IONTOPHORETIC DELIVERY ELECTRODE SYSTEM |
| Baseline Generic Name | IONTOPHORESIS ELECTRODE |
| Baseline Model No | NC89251B |
| Baseline Catalog No | NC89251B |
| Baseline ID | NA |
| Baseline Device Family | BUFFERED IONTOPHORETIC DELIVERY ELECTRODE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K993081 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-10-03 |