MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2002-03-27 for PROELECDT 2 PRO ELECDT 2 * manufactured by Matrix Biokinetics, Inc..
[262724]
Representative from doctors office phoned says having problems with program #8. 3 patients revealed "scab" marks says from treatments with matrix unit. No doctors diagnosis of identified marks. Awaiting report (1) patient "scab" while dosage at 50; (2) while dosage at 9 or 10 per discussion with rep at the doctor's office scab from blister/burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2950881-2002-00001 |
| MDR Report Key | 388977 |
| Report Source | 07,08 |
| Date Received | 2002-03-27 |
| Date of Report | 2002-03-27 |
| Date of Event | 2002-03-25 |
| Date Facility Aware | 2002-03-25 |
| Report Date | 2002-03-27 |
| Date Added to Maude | 2002-04-22 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 6741 W. ALEXANDER RD. |
| Manufacturer City | LAS VEGAS NV 89108 |
| Manufacturer Country | US |
| Manufacturer Postal | 89108 |
| Manufacturer Phone | 7026572001 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROELECDT 2 |
| Generic Name | INTERFERENTIAL CURRENT THERAPY |
| Product Code | LIH |
| Date Received | 2002-03-27 |
| Model Number | PRO ELECDT 2 |
| Catalog Number | * |
| Lot Number | 04 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 378025 |
| Manufacturer | MATRIX BIOKINETICS, INC. |
| Manufacturer Address | 6741 W. ALEXANDER RD. LAS VEGAS NV 89108 US |
| Baseline Brand Name | PROELECDT 2 |
| Baseline Generic Name | INTERFERENTIAL CURRENT THERAPY |
| Baseline Model No | PRO ELECDT 2 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-03-27 |