MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE; DEFIB/PACING ELECTRODE

Model Number 8900-4006

Device Problem Compatibility Problem (2960)

Patient Problem Skin Tears (2516)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown), skin removal/skin tearings were found on the patient upon removal of the electrode pads.Complainant did not indicate if additional treatment for the wounds sustained were required.Please reference medwatch reports: 1218058-2021-00054, 1218058-2021-00055, 1218058-2021-00056, 1218058-2021-00058 and 1218058-2021-00059 for similar events reported from the same customer.

Manufacturer Narrative

The customer was contacted for return of the suspect product.The product has not been returned to zoll for evaluation.

• Brand Name: PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE
• Type of Device: DEFIB/PACING ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 11712652
• MDR Text Key: 246973672
• Report Number: 1218058-2021-00057
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016661
• UDI-Public: 00847946016661
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 8900-4006
• Device Catalogue Number: 8900-4006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other