MAUDE Adverse Event Report: COVIDIEN COVIDIEN TELEMETRY MACHINE; ELECTRODE

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

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Burning Sensation (2146)

Event Date 07/18/2018

Event Type  Injury  

Event Description

I had same day surgery on (b)(6) 2018 at (b)(6) hospital in (b)(6) for a revision / repair of bladder mesh.Dr (b)(6) was my surgeon.I was connected to a telemetry machine to be monitored.Surgery went well.One day post surgery, (b)(6) 2018 i noticed a telemetry patch was still attached to my left flank so i removed it.On (b)(6) 2018, i noticed severe redness, bubbling (but not blisters), and severe itching within the 2 inch patch area.I was treated with otc products with no relief.On (b)(6) 2018 i went to my dermatologist, saw the np, (b)(6), who put me on a betamethasone spray and he told me to take claritin.I did as instructed but the next day, i broke out in raised, reddened rash with severe itching and burning from my neck down to pubis, entire back, a patch on my left forearm, behind my left knee, and edges of both axillae.I called my dr's office who told me to call anesthesia at the hosp.I spoke with the dr of anesthesia who told me it was a telemetry patch.I continued using various otc products with no relief whatsoever.By (b)(6) 2018, i went to (b)(6), a local outpatient clinic and was seen by a pa (b)(6).She placed me on prednisone 60 mg, once a day for 7 days.I slowly improved but still have areas of irritation.I still have a 2" area where the patch was placed as still visible.I did call anesthesia again to obtain the mfr's name of the telemetry device.I assume that the contact gel or what i call the "stickum" caused this severe allergic reaction since the initial reaction was at the patch site.Dose or amount: telemetry patch, frequency: once, route: topical.Dates of use: (b)(6) 2018.Diagnosis or reason for use: contact dermatitis.

• Brand Name: COVIDIEN TELEMETRY MACHINE
• Type of Device: ELECTRODE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 7846395
• MDR Text Key: 119436772
• Report Number: MW5079557
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 67