MAUDE Adverse Event Report: D.O. WEAVER AND COMPANY TEN20 CONDUCTIVE; NEURODIAGNOSTIC ELECTRODE PASTE

Model Number 10-20-1

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Burning Sensation (2146); Skin Inflammation/ Irritation (4545)

Event Date 09/13/2023

Event Type  Injury  

Event Description

On 09/24/23, weaver received a phone complaint from (b)(6), an elderly female patient who underwent an eeg at (b)(6) health in (b)(6) on (b)(6) 2023.Patient alleged, despite her numerous allergies, the staff failed to conduct a skin patch test as directed by the ifu.(b)(6), disclosed she was on medication for thyroid and high blood pressure.(b)(6)reported a burning sensation and itchiness after ten20 was applied to her scalp.The procedure was halted, the patient requested to speak with a doctor, but no doctor was on staff at the clinic for consultation.(b)(6) health staff provided her with ten20 sds and ifu and recommended a warm shower.Her daughter suggested benadryl for the allergic reaction.She tried to see her primary care doctor without success.A follow-up call was scheduled for the next day.On 9/15/23, weaver contact the complainant.(b)(6) revealed that she visited the emergency room at 3 am due to intensified itchiness.She was diagnosed with contact dermatitis, released the same day, and again expressed dissatisfaction with (b)(6) health for not adhering to the ifu due to the patients history of allergies.(b)(6) stated the technician neither inquired about her allergies nor conducted a patch test.(b)(6)mentioned her intent to consult her primary care doctor and confront (b)(6) health about the incident.(b)(6) mentioned that she has had other allergic reactions before and that this reaction was different because it did not cause shortness of breath or require use of an epipen.Another follow-up call was planned.09/15/23 weaver called (b)(6) health seeking additional information.No contact was made, a voicemail was left.On 10/06/23 weaver called the complainant again.(b)(6)'s condition had improved, but she still described itchiness and bumps on her scalp.She informed weaver that the er doctor prescribed claritin, which proved ineffective.She suspected folliculitis and was later switched to zyrtec (at her request), which alleviated some symptoms.(b)(6)expressed dissatisfaction with the clinic's response to her situation.She has scheduled a dermatologist appointment through her primary care doctor.Notably, (b)(6) has allergies to several fruits and possibly chemicals used as food preservatives.She used scalpasin to mitigate scalp itchiness after conducting her own research.The er predicted her symptoms would persist for 2-4 weeks.While her overall condition has improved, her scalp remains inflamed with red pimple-like bumps as described by the complainant.(b)(6) recalled that after a few electrodes were placed, she requested a halt due to the discomfort.She washed her hair immediately, noting the clinic's indifferent attitude, claiming they hadn't witnessed such a reaction before.Two weeks post-incident, (b)(6)'s scalp still burns and itches.She has an appointment with her primary care doctor on (b)(6) 2023.On 10/06/23 and 10/09/23, attempts to contact (b)(6) health via phone for further details, including the used lot number, were unsuccessful.An attempt to gather information via email was sent through the website's contact us page.A follow-up report will be submitted if further information is gained from the healthcare facility.On 10/10/23 weaver called ms.Cc to check on her status.Ms.Cc reported that she is feeling much better, has stopped taking all allergy medications and noticed the itching has decreased substantially.She is scheduled to see the dermatologist on 10/12/23 and is mainly concerned with her hair.Ms.Cc mentioned over the phone that all the washing and treatment of her scalp has caused her hair to become delicate and brittle.Ms.Cc mentioned that all the red bumps on her scalp have dissipated and "dried out".

Manufacturer Narrative

We at weaver and company are actively trying to connect with (b)(6) health to collect further details, including the relevant lot number, any products used for skin preparation, and their narrative of the incident.Based on our interactions with the complainant, we believe the clinic might not have adequately checked the patient's medical history for allergies and may not have adhered to the guidelines in the ifu concerning allergies.(b)(6) indicated that she was handed the ifus by the technician only after the incident.Upon reviewing the ifu and noticing the mention of allergies, she questioned the clinic about their failure to inquire about her allergy history.We feel, had the instructions for use been adhered to, this injury could have been avoided.

• Brand Name: TEN20 CONDUCTIVE
• Type of Device: NEURODIAGNOSTIC ELECTRODE PASTE
• Manufacturer (Section D): D.O. WEAVER AND COMPANY; 565 nucla way; unit b; aurora CO 80011
• Manufacturer Contact: daniel pincus ; 565 nucla way; unit b; aurora, CO 80011 ; 3437201627
• MDR Report Key: 17930796
• MDR Text Key: 325681557
• Report Number: 1718791-2023-23001
• Device Sequence Number: 1
• Product Code: GYB
• UDI-Device Identifier: 000891893002277
• UDI-Public: (01)000891893002277
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K88314917187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10-20-1
• Device Catalogue Number: 10-20-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 70 KG