MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO-PADZ LIQUID GEL RADIOLUCENT MFE, 1 SET; ELECTRODES

Model Number 8900-2106-01

Device Problems Noise, Audible (3273); Patient Device Interaction Problem (4001)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 12/28/2022

Event Type  Injury  

Event Description

Complainant alleged that while attempting to cardiovert a female patient (age unknown), a popping sound was heard.After removing the electrode pads, a blister was found on the patient's skin.Complainant indicated that the patient subsequently sustained a burn.The customer was unable to provide information on the degree of the burn.

Manufacturer Narrative

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

Manufacturer Narrative

The customer was contacted for return of the suspect product.The customer has responded and indicated the has been discarded and the product will not be returning to zoll.

• Brand Name: PRO-PADZ LIQUID GEL RADIOLUCENT MFE, 1 SET
• Type of Device: ELECTRODES
• 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: 16236994
• MDR Text Key: 308042635
• Report Number: 1218058-2023-00010
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016401
• UDI-Public: 00847946016401
• 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: 01/03/2023

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
• Device Operator: Other
• Device Expiration Date: 10/08/2023
• Device Model Number: 8900-2106-01
• Device Catalogue Number: 8900-2106-01
• Device Lot Number: 4122C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/24/2023
• Supplement Dates Manufacturer Received: 01/03/2023
• Supplement Dates FDA Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2022
• 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
• Patient Sex: Female