MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-05 for IONTOPHOR - PM 6111PM N/A manufactured by Life-tech, Inc..
[2569]
Pt. Seen for 1st treatment for iontophoresis, 2 electrodes were placed appropriately, upon conclusion of treatment, electrodes were removed & there were several small blistersinvalid data - regarding single use labeling of device. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: telemetry failure. Conclusion: no failure detected and product within specification, there was no device failure. Certainty of device as cause of or contributor to event: no. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5659 |
| MDR Report Key | 5659 |
| Date Received | 1993-04-05 |
| Date of Report | 1993-03-17 |
| Date of Event | 1993-03-09 |
| Date Facility Aware | 1993-03-09 |
| Report Date | 1993-03-17 |
| Date Added to Maude | 1993-07-20 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IONTOPHOR - PM |
| Generic Name | IONTOPHRESIS |
| Product Code | KTB |
| Date Received | 1993-04-05 |
| Model Number | 6111PM |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 5358 |
| Manufacturer | LIFE-TECH, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-04-05 |