MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, ONESTEP COMPLETE

Model Number 8900-0224-01

Device Problem Human-Device Interface Problem (2949)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that while using electrode pads during a patient code, the electrodes were placed onto the patient, and the clinician chose to lift the electrode and re-adhere.When peeling the electrode from the patient, some of the gel came off the electrode and remained on the patient.When the electrode was re-applied and cpr was performed, the portion of the electrode that was missing the gel had folded over.The electrode had become loose and cut into the patients chest.Complainant indicated that the electrodes were not retained and the lot number is unknown.Complainant indicated that the patient required stitches subsequent to the event.

Manufacturer Narrative

The actual electrodes were not returned to zoll medical corporation for evaluation.A lot number was not provided, therefore review of a retained sample could not be performed.The customer's report could not be confirmed using the pictures provided by the customer.This claim will be closed as no sample returned.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, ONESTEP COMPLETE
• Type of Device: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 6424130
• MDR Text Key: 70552322
• Report Number: 1218058-2017-00035
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016272
• UDI-Public: 00847946016272
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 8900-0224-01
• Device Catalogue Number: 8900-0224-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other