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

Model Number	8900-4004
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	04/23/2021
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 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.
Additional 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
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 11913293
• Report Number: 1218058-2021-00076
• Device Sequence Number: 17029438
• Product Code: MKJ
• UDI-Device Identifier: 00847946016456
• UDI-Public: 00847946016456
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 06/30/2021
• 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