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U.S. Department of Health and Human Services

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

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D.O. WEAVER AND COMPANY TEN20 CONDUCTIVE; NEURODIAGNOSTIC ELECTRODE PASTE Back to Search Results
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.
 
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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 Key17930796
MDR Text Key325681557
Report Number1718791-2023-23001
Device Sequence Number1
Product Code GYB
UDI-Device Identifier000891893002277
UDI-Public(01)000891893002277
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K88314917187
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number10-20-1
Device Catalogue Number10-20-1
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/14/2023
Initial Date FDA Received10/13/2023
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 Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age55 YR
Patient SexFemale
Patient Weight70 KG
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