MAUDE Adverse Event Report: 3M HEALTH CARE 3M RED DOT(TM) RESTING EKG ELECTRODE

Catalog Number 2360

Device Problem No Apparent Adverse Event (3189)

Patient Problem Rash (2033)

Event Date 12/23/2015

Event Type  Injury  

Manufacturer Narrative

Pt info not provided; no lot number was provided.Without lot number can not provide expiration date nor device manufacture date.Product used was not available for evaluation.End of report.Device has not been returned.

Event Description

A doctor reported that a (b)(6) male with unspecified cardiac issues had 3m red dot(tm) electrodes placed on his skin on (b)(6) 2015.Details about skin preparation and number of electrodes were not specified.The boy allegedly developed "contact irritation" and a full systemic body rash starting within a few minutes after application.The rash was maculopapular without hives or urticaria.The rash covered the boy's body with the exception of palms, soles, face and genitals.There was no mucous membrane involvement and no evidence of anaphylaxis.The boy was given benadryl¿(diphenhydramine).It was unclear if any additional treatment was given.The boy had no fever at the time of the rash and was not taking medications.The rash remained two weeks later.

• Brand Name: 3M RED DOT(TM) RESTING EKG ELECTRODE
• Type of Device: ELECTRODE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY VALLEY PLANT; 600 east meigs st.; valley NE 68064
• Manufacturer Contact: linda johnsen ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517374376
• MDR Report Key: 5414489
• MDR Text Key: 37611994
• Report Number: 2110898-2016-00010
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 2360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10 YR