MAUDE Adverse Event Report: 3M HEALTH CARE 3M RED DOT (TM) ELECTRODE; ECG ELECTRODE

Model Number N/A

Device Problem Missing Value Reason (3192)

Patient Problem Scar Tissue (2060)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

No information provided.There was no given lot number for the product.Without lot number it is not possible to determine the expiration date or manufacture date.Note: the model of electrode used by the customer was not known to the customer.Attempts made to obtain this information from the hospital were unsuccessful.The man was given unspecified intravenous medication while in the hospital.It is possible that a full body rash could be related to the medication.Scars were noted to be applicable under the electrodes and reason for this report.End of report.Device not return and no lot number.

Event Description

A male customer, age unspecified, reported that he went to the hospital emergency room on (b)(6) 2016.Reason was not specified.3m red dot(tm) electrodes (model not specified) were applied to the man's torso.The man did not recall if his skin was prepped before application.Duration of wear was not specified.The man denied any issues during or immediately after removal of the electrodes.On (b)(6), the man alleged itching and a red rash where the electrodes were applied.He also indicated that medical tape (model not specified) had been applied to hold iv tubing in place.The man alleged the rash spread over his body.He was seen by his primary care physician who prescribed an unspecified topical product and an oral "anti-itch" medication.The man did not fill the prescriptions but self-treated with products.The man stated that the body rash resolved but he alleged that marks under the electrodes remained one month later.The man denied any known allergies.

• Brand Name: 3M RED DOT (TM) ELECTRODE
• Type of Device: ECG 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: 6323765
• MDR Text Key: 67210716
• Report Number: 2110898-2017-00010
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2017
• 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
• Treatment: MEDICAL TAPE (TYPE NOT SPECIFIED)
• Patient Outcome(s): Other