MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-04-04 for NEOTRODE II; 3; WIRE TP ADGEL 1741-003 manufactured by Consolidated Medical Equipment.
[140945472]
The 1741-003 device is not expected to be returned for evaluation and review. This complaint of patient received burn from device is unable to be verified and a root cause cannot be determined. The manufacturing documents from the device history record cannot be reviewed since the device lot number is unknown. Also a lot history review of this device cannot be conducted due to the lot number not being known. A two-year review of complaint history revealed there has been a total of two complaints, regarding two devices, for this device family and failure mode. During this same time frame (b)(4) devices have been manufactured and shipped worldwide. Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4). Per the instructions for use, the user is advised the following: warnings: no modification of electrodes is allowed. Modification may result in patient or operator harm. During surgical procedures place ecg electrodes and leads as far as possible from the electrosurgical site to minimize rf current flow through ecg electrodes. Placement is important in reducing the potential harm in the event of defect in the dispersive electrode. Cautions: the electrode site should be dry before electrode application. Fluids, including skin cleansing solutions, lotions or soapy water may cause skin irritation and loss of adhesion. Keep electrode site dry. Rapid removal of the electrode from the patient may cause skin damage. In rare instances, alteration of skin pigmentation or skin sensitization may occur after electrode removal. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[140945473]
The customer reported that 1741-003, neotrode ii; 3; wire tp adgel, device was being used during an unknown procedure on (b)(6) 2019. The reported states that "patient showed signs of a burn after electrode was removed, the wound care group will be doing continuous monitoring of the patient". The reported also stated that "2-hours to move the patient and leave the room intact for wound care investigator to review". Further information has been requested and the reporter stated that they are attempting to gain the answers; however, to date, there has not been any response for information. This report is being raised on the basis of injury due to a reported burn with no further assessment information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007305485-2019-00094 |
| MDR Report Key | 8483977 |
| Report Source | USER FACILITY |
| Date Received | 2019-04-04 |
| Date of Report | 2019-04-04 |
| Date of Event | 2019-03-13 |
| Date Mfgr Received | 2019-03-14 |
| Date Added to Maude | 2019-04-04 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOHN BERGA |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995358 |
| Manufacturer G1 | CONSOLIDATED MEDICAL EQUIPMENT |
| Manufacturer Street | ALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA |
| Manufacturer City | CHIHUAHUA, 31136 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 31136 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOTRODE II; 3; WIRE TP ADGEL |
| Generic Name | ELECTRODE, ELECTROCARDIOGRAPH |
| Product Code | DRX |
| Date Received | 2019-04-04 |
| Catalog Number | 1741-003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONSOLIDATED MEDICAL EQUIPMENT |
| Manufacturer Address | ALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA CHIHUAHUA, 31136 MX 31136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-04 |