MAUDE Adverse Event Report: CARDINAL HEALTH ALL-PURPOSE FOAM ELECTRODES; ELECTRODE ELECTROCARDIOGRAPHY

Model Number MFR# 87-50SG

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rash (2033)

Event Date 11/12/2016

Event Type  Injury  

Event Description

Had cardiac leads attached to skin for monitoring activity.After 4 days developed, terrible rash across lower ribs with blistering.Doctor said it resembled shingles but was certain it was allergic since i have had shingles and this involved two areas.I spoke with maker of the adhesive and leads, cardinal health, and requested information on composition of adhesive used; they refused.They stated it was ¿proprietary information¿ and could not be divulged.My physician husband sent message to place him in contact with medical director to be certain i did not use possible allergic material again.That was over 2 weeks ago with no response.Photographs of the acute topical reaction at it's worse.Seven days post exposure around (b)(6) 2018.

• Brand Name: ALL-PURPOSE FOAM ELECTRODES
• Type of Device: ELECTRODE ELECTROCARDIOGRAPHY
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 8110729
• MDR Text Key: 128862077
• Report Number: MW5081654
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/31/2021
• Device Model Number: MFR# 87-50SG
• Device Catalogue Number: MFR# 87-50SG
• Device Lot Number: 813141
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 50