MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-02-27 for UNK EL manufactured by Covidien.
[68401439]
An investigation is currently under way; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[68401440]
The customer reports two weeks ago he was at (b)(6) with chest pain. They did an ekg and applied electrodes. He arrived home at about 1:00am and went to sleep. When he woke up the electrodes were still in place. When he removed the electrodes he states? There were chemical burns at the electrode sites?. He spoke with some nurse friends from the va who told him that this would cause permanent scarring. He is currently at (b)(6) to see a nurse practitioner regarding the? Burns?. She ordered him a steroid cream for the burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219103-2017-05000 |
| MDR Report Key | 6360795 |
| Report Source | USER FACILITY |
| Date Received | 2017-02-27 |
| Date of Report | 2017-02-06 |
| Date of Event | 2017-01-31 |
| Date Mfgr Received | 2017-02-06 |
| Date Added to Maude | 2017-02-27 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 2 LUDLOW PARK DRIVE |
| Manufacturer City | CHICOPEE 01022 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01022 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | IKD |
| Date Received | 2017-02-27 |
| Model Number | UNK EL |
| Catalog Number | UNK EL |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 2 LUDLOW PARK DRIVE CHICOPEE 01022 US 01022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-27 |