MAUDE Adverse Event Report: VITALCONNECT, INC. VITALPATCH; BIOSENSOR

Model Number 4007-01

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Contact Dermatitis (4546)

Event Date 07/25/2021

Event Type  Injury  

Manufacturer Narrative

The instructions for use which accompany the vitalpatch device provide several warning and precautions regarding use of the vitalpatch device.These warnings and precautions inform the healthcare practitioner and the patient that (a) histories of skin irritation should be considered before placing the vitalpatch device on a patient, (b) the adhesives in this product may cause adverse skin reactions, such as a severe adverse event or severe allergic reaction, (c) the vitalpatch should not be submerged or used in a sauna.It is not known whether this patient had a pre-existing allergy to the vitalpatch adhesives, although she reported several known types of allergies/allergens.The patient also described wearing the vitalpatch while swimming in a pool.The hydrocolloid adhesive used on the vitalpatch is designed to absorb fluids, such as body sweat and may have absorbed pool water -- thus exposing the patient's skin to chlorine for an extended period of time (chlorine is a known skin irritant).

Event Description

This is a (b)(6) caucasian female who declined to share her full medical history with a vitalconnect nurse, but did disclose the following known allergies: medication allergies: augmentin and prozac environmental/ food allergies: wheat, peanuts, horses and cats (causes welts and blisters with exposure).She denies sensitivity to latex or adhesives prior to this event.On (b)(6) 20201, a vitalconnect representative received a report of skin irritation on a (b)(6)caucasian female from a cardiologist at a heart clinical in (b)(6).The patient had given permission for a vitalconnect representative to contact her directly.A phone call was placed to the patient by a vitalconnect nurse and the patient returned the call on (b)(6) 2021.During the call, the patient stated that she had an appointment on (b)(6) with her cardiologist at the cardiology facility where she was patched with the vitalconnect vitalpatch for a 28 day study.She reports that her cardiologist informed her that vitalconnect was a new company and he wanted to try this new patch on her because of its versatility.She also reports that she was given instructions that she could shower, exercise, and swim in the patch as long as she did not stay in the water for more than 30 minutes.She asked if it was ok to be out in the sun wearing the patch and was told that this should be ok.The patient stated that she was given a total of 4 patches and had been changing them out every thursday evening.At the end of the second patch period ((b)(6)) she changed to her 3rd patch and had no skin irritation up to this point.She reported that she went swimming in a chlorinated pool on (b)(6) and reported that the only water exposure up to this point had been via showering.Early evening of (b)(6) the patient reports that she noted that her skin was becoming increasingly red and itchy around the periphery of the vitalpatch and by late evening she reported that her skin was burning with increased itching and the skin around and under the patch was now raised and notably more red.She reported that because of the increasing discomfort she could no longer tolerate wearing the patch and decided to remove it.She states that she used the adhesive remover pad that was provided but found that the patch was very difficult to remove, which had not been the case with the previous 2 patches she had worn.She reported that when she finally did get the patch off of her skin, she noticed that the adhesive on the patch appeared "melted" and she had "pieces" of the adhesive on her skin in each area where the adhesive of the patch touched her skin.She attempted to remove the remaining residue on her skin with the adhesive remover and also tried an alcohol wipe, which "hurt" her skin, and was still unable to remove all of the adhesive residue from her skin.She reports that she washed the area with a gentle soap and allowed the area to air dry overnight.The patient reported that when she awoke the next morning her skin seemed "more irritated" than the night before.The patient works as an ma at her primary care physician's office and reports that when she arrived at work that morning she asked one of the physician assistants in the office to assess her skin.She reports that the pa applied some polysporin to the irritated areas and applied a telfa dressing.The following morning (b)(6) arrived at work and removed the dressing to find that blisters had now developed and her skin remained red and painful.The primary care physician she works for then assessed her skin and informed the patient that she felt that she had experienced a "chemical burn".She states that she was prescribed silvadene cream that she applied for 4 consecutive days with noted improvement and relief daily.She did state that she was using paper tape to hold the telfa dressing in place but ran out one night and used nylon tape that did cause irritation to her skin, which is new for her.She reports that her skin is healing well and there is no scarring present.The vitalconnect nurse reviewed with the patient the information contained in the vitalpatch instructions for use that states "the vitalpatch device may be used while showering.Minimize exposure directly under the shower head, excessive contact with soap, or scrubbing.Gently dry the device after showering.Do not submerge the device or use it in a sauna." the vitalconnect nurse also confirmed that the patient did receive the quickstart guide from her cardiologists' office and referred her to pg.3 which states "do not swim with the vitalpatch or use it in a sauna, steam room or hot tub".The patient declined to share her full medical history with a vitalconnect nurse, but did disclose the following known allergies (and provided 3 photographs of the irritated skin on her upper chest area): medication allergies: augmentin and prozac.Environmental/ food allergies: wheat, peanuts, horses and cats (causes welts and blisters with exposure).She denies sensitivity to latex or adhesives prior to this event.

• Brand Name: VITALPATCH
• Type of Device: BIOSENSOR
• Manufacturer (Section D): VITALCONNECT, INC.; 224 airport parkway; suite 300; san jose CA 95110
• Manufacturer (Section G): VITALCONNECT, INC.; 224 airport parkway; suite 300; san jose CA 95110
• Manufacturer Contact: edward sinclair ; 224 airport parkway; suite 300; san jose, CA 95110 ; 6502189149
• MDR Report Key: 12388721
• MDR Text Key: 268903789
• Report Number: 3010830833-2021-00001
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 00850490007450
• UDI-Public: 00850490007450
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4007-01
• Device Catalogue Number: 4007-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2021
• 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): Other
• Patient Age: 25 YR