MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-24 for CARDIOKEY 700-0122-01 REV G 700-0123-03 manufactured by Biotel Heart / Biotelemetry, Inc. / Braemar Manufacturing, Llc..
[131769541]
I had an allergic reaction to the electrodes for the cardiokey extended holter monitoring manufactured by bio tel, (b)(4). The sku appears to be (b)(4). The recorder number was (b)(4). This was to be a 14- day heart monitor. After the fourth day, i began to experience itchiness of the skin in contact with the electrodes. By day 7,the skin was red, tender, and the skin was no longer intact. I stopped wearing the monitoring device and returned it to the manufacturer. I notified my cardiologist and also the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082570 |
| MDR Report Key | 8196649 |
| Date Received | 2018-12-24 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-12-04 |
| Date Added to Maude | 2018-12-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | CARDIOKEY |
| Generic Name | ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS) |
| Product Code | MWJ |
| Date Received | 2018-12-24 |
| Model Number | 700-0122-01 REV G |
| Catalog Number | 700-0123-03 |
| Lot Number | 06618V11 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BIOTEL HEART / BIOTELEMETRY, INC. / BRAEMAR MANUFACTURING, LLC. |
| Brand Name | CARDIOKEY |
| Generic Name | ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS) |
| Product Code | MWJ |
| Date Received | 2018-12-24 |
| Model Number | 700-0122-01 REV G |
| Catalog Number | 700-0123-03 |
| Lot Number | 06618V11 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTEL HEART / BIOTELEMETRY, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-24 |