MAUDE Adverse Event Report: BIO-DETEK INCORPORATED STAT PADZ HVP MULTI FUNCTION ELECTRODES

Model Number 8900-4004

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Tears (2516)

Event Date 04/23/2021

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 and gender unknown), after 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 skin tear.The skin tear was treated with petroleum, gauze, and tegaderm.

Manufacturer Narrative

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

• Brand Name: STAT PADZ HVP MULTI FUNCTION ELECTRODES
• Type of Device: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 11913293
• MDR Text Key: 253526353
• Report Number: 1218058-2021-00076
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016456
• UDI-Public: 00847946016456
• 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: 05/12/2021

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: 03/06/2023
• Device Model Number: 8900-4004
• Device Catalogue Number: 8900-4004
• Device Lot Number: 1021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 06/01/2021
• Supplement Dates Manufacturer Received: 05/12/2021
• Supplement Dates FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other