MAUDE Adverse Event Report: COVIDIEN PUPPYDOG 5 LEADS; ELECTRODE EKG

Catalog Number 31424780

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Tissue Damage (2104)

Event Date 12/13/2015

Event Type  malfunction  

Event Description

We have experienced 6 events involving the 5 leads over the last 2 months.The events involve skin issues including blistering and rashes on the abdomen/chest area.The leads were immediately removed and replaced with a different manufacturer's leads, which have not been problematic.Once the medline/covidien leads are removed, the red spots are still noted after 12 hours.Covidien has been contacted and has been on-site to educate and discuss the process for applying the leads.Staff are using the saline wipes and gauze method prior to application.Covidien has completed medsun [medwatch] reports involving the 5 lead products.

• Brand Name: PUPPYDOG 5 LEADS
• Type of Device: ELECTRODE EKG
• Manufacturer (Section D): COVIDIEN; two ludlow park drive; chicopee MA 01022
• MDR Report Key: 5433414
• MDR Text Key: 38098223
• Report Number: 5433414
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2016,02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 31424780
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 YR