MAUDE Adverse Event Report: COVIDIEN UNKNOWN TELEMETRY PATCH; ELECTRODE, ELECTROCARDIOGRAPH

Model Number UNKNOWN ELECTRODE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Irritation (2076)

Event Date 07/18/2018

Event Type  Injury  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer states they had same day surgery at a hospital for a revision/repair of bladder mesh.The patient was connected to a telemetry machine to be monitored.Surgery went well.One day post-surgery, the patient noticed a telemetry patch was still attached to their left flank and removed it.The patient noticed severe redness, bubbling (but not blisters) and severe itching within the 2 inch patch area.They were treated with over the counter (otc) products with no relief.The patient went to their dermatologist and saw the nurse practitioner (np) who put them on a betamethasone spray and told the patient to take claritin.The patient did as instructed but the next day broke out in a raised, reddened rash with severe itching and burning from the neck down to the pubis and entire back.There was a patch on the left forearm, behind the left knee, and on the edges of both axillae.The patient spoke with the dr.Of anesthesia who told them it was a telemetry patch.The patient continued using various otc products with no relief.The patient went to a local outpatient clinic and was seen by a physician¿s assistant (pa).She placed the patient on prednisone 60 mg, once a day for 7 days.The patient slowly improved but still has an area of irritation.The patient has a 2" area where the patch was placed still visible.The patient called anesthesia again to obtain the manufacturer¿s name of the telemetry device.

• Brand Name: UNKNOWN TELEMETRY PATCH
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): COVIDIEN; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• Manufacturer (Section G): COVIDIEN; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7935582
• MDR Text Key: 122794409
• Report Number: 9681860-2018-00501
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN ELECTRODE
• Device Catalogue Number: UNKNOWN ELECTRODE
• Date Manufacturer Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention