MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO-PADZ LIQUID GEL RADIOLUCENT MFE; ELECTRODE

Model Number	8900-2106-01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to cardiovert a patient (age & gender unknown), after removing the electrode pads, burns were found on the patient's skin.Patient sustained burnmarks, no information provided on the degree of burn the patient received.
Additional Manufacturer Narrative
The pro padz liquid gel radiolucent electrodes were not received at zoll for evaluation.The lot number of the pads was not provided; therefore retained sample testing could not be performed.No clinical data or photographs of the patient's burn were provided.Poor adherence and /or air under the electrodes can lead to the possibility of arcing and skin burns.Our electrode labeling calls out the importance of good placement on the patient and provides instructions for proper electrode application technique.Good skin preparation does not guarantee a burn will not occur and burns from defibrillation is an expected risk.

• Brand Name: PRO-PADZ LIQUID GEL RADIOLUCENT MFE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 9535142
• Report Number: 1218058-2019-00189
• Device Sequence Number: 11610353
• Product Code: MKJ
• UDI-Device Identifier: 00847946016401
• UDI-Public: 00847946016401
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 8900-2106-01
• Device Catalogue Number: 8900-2106-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other