MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-13 for VERMED ECG MONITORING ELECTRODES manufactured by Nissha Fis, Inc.
[117255775]
I was wearing a 30 day heart monitor and the leads made large burns on my skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079121 |
| MDR Report Key | 7780311 |
| Date Received | 2018-08-13 |
| Date of Report | 2018-08-09 |
| Date of Event | 2018-07-22 |
| Date Added to Maude | 2018-08-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VERMED ECG MONITORING ELECTRODES |
| Generic Name | ELECTRODE ELECTROCARDIOGRAPH |
| Product Code | DPS |
| Date Received | 2018-08-13 |
| Lot Number | 50117V13 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NISSHA FIS, INC |
| Manufacturer Address | 1051 PERIMETER DR STE 600 SCHAUMBURG IL 60173 US 60173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-13 |