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

Model Number 8900-4006

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Erosion (2075)

Event Type  Injury  

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown), after a 24 hour placement of the electrode pads on the patient, upon removal of the pads, skin removal/tearing was found on the patient's skin.Complainant indicated that the patient skin sustained tearing.

Manufacturer Narrative

The actual electrode pads involved were discarded by the customer and not available for evaluation.Photographs of the patient's injuries were provided for review.The photo's were consistent with the customer report, as well as additional trauma to the patient (that dont; appear to be related to the electrode pads).Skin condition at the time, protocol and the number of shocks delivered are unknown.It could not be determined if the electrode pads were the main contributor and it was acknowledged by the customer that the patien't skin was more fragile than it appeared in the photographs.Retained sample testing of the lot number 3119a provided could add no value to this investigation.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE, SINGLE
• Type of Device: DEFIB/PACING ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 10224340
• MDR Text Key: 197318213
• Report Number: 1218058-2020-00051
• 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: 06/12/2020

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: 07/29/2020
• Device Model Number: 8900-4006
• Device Catalogue Number: 8900-4006
• Device Lot Number: 3119A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: 06/12/2020
• Supplement Dates FDA Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other