MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO PADZ, MFE, RADIOLUCENT, ADULT, HVP; DEFIB/PACING ELECTRODE

Model Number 8900-4005

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Skin Erosion (2075); 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.Please refer to the attached user medwatch report that zoll medical has received.

Event Description

Complainant alleged that while attempting to treat a patient (age and gender unknown), after a 24 hour placement of the electrode pads on the patient, upon removal of the pads, skin integrity issues were found on the patient.Complainant indicated that the patient subsequently sustained a serious injury.The customer provided information on the patient's injury which were skin tearing and blistering.

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, MFE, RADIOLUCENT, ADULT, HVP
• Type of Device: DEFIB/PACING ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 9454460
• MDR Text Key: 170447237
• Report Number: 1218058-2019-00165
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K960676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

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
• Device Operator: Other
• Device Model Number: 8900-4005
• Device Catalogue Number: 8900-4005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 11/20/2019
• Supplement Dates FDA Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other