MAUDE Adverse Event Report: COVIDIEN LP JUAREZ (MMJ) BIS; ELECTRODE, CUTANEOUS

Model Number 186-0106

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

Title: contact dermatitis associated with the bispectral index¿ sensor: a case report source: taguchi et al.Ja clinical reports (2020) 6:87 published online: 28 october 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed, the monitor and sensor were used on patient during tooth extraction under general anesthesia.The sensor was attached in a routine manner after alcohol skin preparation.The patient was discharged from the hospital with no complication.Three days after surgery, she felt itching sensations and burning pain and noticed erythema on her forehead.It was identified that the patient had contact dermatitis.The patient was administered topical steroids and antihistamines.Erythema peaked on the fifth postoperative day and improved gradually thereafter.One month after surgery, patch testing for allergic reactions to the sensor was performed.After 48 hours and 72 hours, a positive reaction to the adhesive component of the sensor was observed.The reaction to the foam component was positive after 48 hours, but it tended to disappear after 72 hours.The patient also had reactions to p-tert-butylphenol-formaldehyde resin (ptbp-f-r) and lanolin using a japanese standard patch test series.Article: contact dermatitis associated with the bispectral index¿ sensor: a case report, noriko taguchi, 2020, springer.

• Brand Name: BIS
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): COVIDIEN LP JUAREZ (MMJ); 9560 jose rodriguez drive; el paso TX 79927
• Manufacturer (Section G): COVIDIEN LP JUAREZ (MMJ); 9560 jose rodriguez drive; el paso TX 79927
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 11019936
• MDR Text Key: 227874208
• Report Number: 2936999-2020-00930
• Device Sequence Number: 1
• Product Code: GXY
• UDI-Device Identifier: 20884521134307
• UDI-Public: 20884521134307
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2014
• Device Model Number: 186-0106
• Device Catalogue Number: 186-0106
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2020
• 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 Age: 38 YR