MAUDE Adverse Event Report: WOOSHIN LABOTTACH CO., LTD. MIDOL HEAT VIBES; PACK, HOT OR COLD, DISPOSABLE

Lot Number BU22172

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Burn(s) (1757); Skin Burning Sensation (4540)

Event Date 01/30/2023

Event Type  Injury  

Event Description

Bayer case number: (b)(4).This spontaneous case was reported by a consumer and describes the occurrence of thermal burn ("i discovered severe burns under the patch after removing it from my skin") in an adult patient who applied midol heat vibes medicated plaster for pain.Additional non-serious events are detailed below.Product or product use issues identified: wrong technique in device usage process ("after applying it directly to my skin").There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2023, the patient applied midol heat vibes 1df once.On (b)(6) 2023, the day of midol heat vibes initiation, the patient experienced thermal burn (seriousness criterion medically important), application site wound ("when i arrived home from work, i removed the patch and several layers of skin along with it") and application site pain ("it is very painful").At the time of the report, the thermal burn, application site wound and application site pain had not resolved.The reporter considered application site pain, application site wound and thermal burn to be related to midol heat vibes administration.The reporter commented: obviously i should have read all of the instructions but i was in so much pain that i assumed these patches worked like other patches i have used for pain.After applying it directly to my skin for my work shift, i discovered severe burns under the patch after removing it from my skin.I have a photo of my burn if requested.Follow-up information received on 04-feb-2023: i would like to pass along information about the burn i received.I wore the patch on monday and it was directly on my skin.At no point during the time i wore it did it feel as though my skin was burning or being damaged.When i arrived home from work, i removed the patch and several layers of skin along with it.I did not take photos initially but i took a photo of the burned area on thursday (4 days after the burn) and will attach that below.I am unsure if this is a chemical burn or burn caused by heat but it is very painful.I want this information shared as i realize i did not follow instructions and assumed these patched worked like every other pain patch i have used and applied it directly to my skin.I don´t want this happening to other people.It truly hurts.Thermal burn ("i discovered severe burns under the patch after removing it from my skin") is unlisted in the reference safety information of midol heat vibes ( no active ingredient).Given that the patient used the product in a wrong way, plus, the strong temporal relation, causality between the event and the product cannot be excluded at the time ( related).

Event Description

Bayer case number: (b)(4).This spontaneous case was reported by a consumer and describes the occurrence of medical device site burn ('i discovered severe burns under the patch after removing it from my skin') in a 42-year-old female patient who received midol heat vibes medicated plaster (batch no.Bu22172) for pain.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: wrong technique in device usage process "after applying it directly to my skin" on (b)(6) 2023.The patient's medical history included hypertension, anxiety, neck surgery, cesarean section and c-section.Concomitant products included amlodipine (amlodil), cetirizine, escitalopram and lisinopril.On an unknown date, the patient started midol heat vibes.On 30-jan-2023, the patient experienced medical device site burn (seriousness criterion medically significant), application site wound ("when i arrived home from work, i removed the patch and several layers of skin along with it") and application site pain ("it is very painful").At the time of the report, the medical device site burn, application site wound and application site pain had not resolved.The reporter considered application site pain, application site wound and medical device site burn to be related to midol heat vibes.The reporter commented: obviously i should have read all of the instructions but i was in so much pain that i assumed these patches worked like other patches i have used for pain.After applying it directly to my skin for my work shift, i discovered severe burns under the patch after removing it from my skin.I have a photo of my burn if requested.Follow-up information received on 04-feb-2023: i would like to pass along information about the burn i received.I wore the patch on monday and it was directly on my skin.At no point during the time i wore it did it feel as though my skin was burning or being damaged.When i arrived home from work, i removed the patch and several layers of skin along with it.I did not take photos initially but i took a photo of the burned area on thursday (4 days after the burn) and will attach that below.I am unsure if this is a chemical burn or burn caused by heat but it is very painful.I want this information shared as i realize i did not follow instructions and assumed these patched worked like every other pain patch i have used and applied it directly to my skin.I don´t want this happening to other people.It truly hurts.Quality-safety evaluation of ptc: a ptc investigation cannot be conducted by the quality unit as a batch number or sample was not provided.A quality defect could not be confirmed.The complaint was deemed to have likely occurred due to user handling error of device.This complaint is subject to routine signaling, trending according to established procedures.Any need for a corrective and/or preventive action is determined in response to the respective signal.Most recent follow-up information incorporated above includes: on 15-feb-2023: quality-safety evaluation of ptc: unconfirmed quality defect, final report of device tab was ticked, eu/ca and eu/mir fields were updated and ptc global number was added on 15-feb-2023: lot number and expiration date of device was added.Thermal burn ("i discovered severe burns under the patch after removing it from my skin") is unlisted in the reference safety information of midol heat vibes ( no active ingredient).Given that the patient used the product in a wrong way, plus, the strong temporal relation, causality between the event and the product cannot be excluded at the time ( related).Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Event Description

Bayer case number: (b)(4).This spontaneous case was reported by a consumer and describes the occurrence of application site burn ('i discovered severe burns under the patch after removing it from my skin') in a 42-year-old female patient who received midol heat vibes medicated plaster for pain.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: wrong technique in device usage process "after applying it directly to my skin" on (b)(6) 2023.The patient's medical history included hypertension and anxiety.Concomitant products included amlodipine (amlodil), cetirizine, escitalopram and lisinopril.On (b)(6) 2023, the patient received midol heat vibes, 1 dosage form(s) once.On (b)(6) 2023, the patient experienced application site burn (seriousness criterion medically significant), application site wound ("when i arrived home from work, i removed the patch and several layers of skin along with it") and application site pain ("it is very painful").At the time of the report, the application site burn, application site wound and application site pain had not resolved.The reporter considered application site burn, application site pain and application site wound to be related to midol heat vibes.The reporter commented: obviously i should have read all of the instructions but i was in so much pain that i assumed these patches worked like other patches i have used for pain.After applying it directly to my skin for my work shift, i discovered severe burns under the patch after removing it from my skin.I have a photo of my burn if requested.Follow-up information received on 04-feb-2023: i would like to pass along information about the burn i received.I wore the patch on monday and it was directly on my skin.At no point during the time i wore it did it feel as though my skin was burning or being damaged.When i arrived home from work, i removed the patch and several layers of skin along with it.I did not take photos initially but i took a photo of the burned area on thursday (4 days after the burn) and will attach that below.I am unsure if this is a chemical burn or burn caused by heat but it is very painful.I want this information shared as i realize i did not follow instructions and assumed these patched worked like every other pain patch i have used and applied it directly to my skin.I don´t want this happening to other people.It truly hurts.Thermal burn ("i discovered severe burns under the patch after removing it from my skin") is unlisted in the reference safety information of midol heat vibes ( no active ingredient).Given that the patient used the product in a wrong way, plus, the strong temporal relation, causality between the event and the product cannot be excluded at the time ( related).Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Event Description

Bayer case number: (b)(4).This spontaneous case was reported by a consumer and describes the occurrence of medical device site burn ('i discovered severe burns under the patch after removing it from my skin') in a 42-year-old female patient who received midol heat vibes medicated plaster (batch no.Bu22172) for pain.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: wrong technique in device usage process "after applying it directly to my skin" on (b)(6) 2023.The patient's medical history included hypertension, anxiety, neck surgery, cesarean section and c-section.Concomitant products included amlodipine (amlodil), cetirizine, escitalopram and lisinopril.On an unknown date, the patient started midol heat vibes.On (b)(6) 2023, the patient experienced medical device site burn (seriousness criterion medically significant), application site wound ("when i arrived home from work, i removed the patch and several layers of skin along with it") and application site pain ("it is very painful").At the time of the report, the medical device site burn, application site wound and application site pain had not resolved.The reporter considered application site pain, application site wound and medical device site burn to be related to midol heat vibes.The reporter commented: obviously i should have read all of the instructions but i was in so much pain that i assumed these patches worked like other patches i have used for pain.After applying it directly to my skin for my work shift, i discovered severe burns under the patch after removing it from my skin.I have a photo of my burn if requested.Follow-up information received on 04-feb-2023: i would like to pass along information about the burn i received.I wore the patch on monday and it was directly on my skin.At no point during the time i wore it did it feel as though my skin was burning or being damaged.When i arrived home from work, i removed the patch and several layers of skin along with it.I did not take photos initially but i took a photo of the burned area on thursday (4 days after the burn) and will attach that below.I am unsure if this is a chemical burn or burn caused by heat but it is very painful.I want this information shared as i realize i did not follow instructions and assumed these patched worked like every other pain patch i have used and applied it directly to my skin.I don´t want this happening to other people.It truly hurts.Quality-safety evaluation of ptc: based on the technical investigation, batch record and retain samples were reviewed and no deviations or nonconformances were found.This is the first complaint received for batch bu22172.No issues that could negatively affect product quality were detected.The consumer provided two photographs of the adverse event they experienced, and also admits that they did not read the instructions for use and applied the patch directly to the skin.The product directions state to not let neither side of the patch to come in direct contact with skin and to never adhere patch directly to bare skin.No complaint sample was received for investigation at responsible quality unit (rqu).Investigation of reported batch records and retained samples was conducted and the outcome of the investigation resulted in an unconfirmed quality defect.Therefore there is no reason to suspect a causal relationship between the reported medical events and a quality defect.The complaint was deemed to have occurred due to user handling error of device.This complaint is subject to routine signaling, trending according to established procedures.Any need for a corrective and/or preventive action is determined in response to the respective signal.Most recent follow-up information incorporated above includes: on 27-feb-2023: quality-safety evaluation of ptc, unconfirmed quality defect, update of global ptc number, pdf attached, update of imdrf annex b.Thermal burn ("i discovered severe burns under the patch after removing it from my skin"), application site pain and application site wound are unlisted in the reference safety information of midol heat vibes (no active ingredient) while wrong technique in device usage process is listed.Given that the patient used the product in a wrong way, plus, the strong temporal relation, causality between the events and the product cannot be excluded at the time (related).Based on the available information, a review of our complaint records and other relevant data was conducted (unconfirmed quality defect); any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Event Description

Bayer case number: (b)(4).This spontaneous case was reported by a consumer and describes the occurrence of medical device site burn ('i discovered severe burns under the patch after removing it from my skin') in a 42-year-old female patient who received midol heat vibes medicated plaster (batch no.Bu22172) for pain.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: wrong technique in device usage process "after applying it directly to my skin" on (b)(6) 2023.The patient's medical history included hypertension, anxiety, neck surgery, cesarean section and c-section.Concomitant products included amlodipine (amlodil), cetirizine, escitalopram and lisinopril.On an unknown date, the patient started midol heat vibes.On (b)(6) 2023, the patient experienced medical device site burn (seriousness criterion medically significant), application site wound ("when i arrived home from work, i removed the patch and several layers of skin along with it") and application site pain ("it is very painful").At the time of the report, the medical device site burn, application site wound and application site pain had not resolved.The reporter considered application site pain, application site wound and medical device site burn to be related to midol heat vibes.The reporter commented: "obviously i should have read all of the instructions but i was in so much pain that i assumed these patches worked like other patches i have used for pain.After applying it directly to my skin for my work shift, i discovered severe burns under the patch after removing it from my skin.I have a photo of my burn if requested." follow-up information received on 04-feb-2023: i would like to pass along information about the burn i received.I wore the patch on monday and it was directly on my skin.At no point during the time i wore it did it feel as though my skin was burning or being damaged.When i arrived home from work, i removed the patch and several layers of skin along with it.I did not take photos initially but i took a photo of the burned area on thursday (4 days after the burn) and will attach that below.I am unsure if this is a chemical burn or burn caused by heat but it is very painful.I want this information shared as i realize i did not follow instructions and assumed these patched worked like every other pain patch i have used and applied it directly to my skin.I don´t want this happening to other people.It truly hurts.Quality-safety evaluation of ptc: based on the technical investigation, batch record and retain samples were reviewed and no deviations or nonconformances were found.This is the first complaint received for batch bu22172.No issues that could negatively affect product quality were detected.The consumer provided two photographs of the adverse event they experienced, and also admits that they did not read the instructions for use and applied the patch directly to the skin.The product directions state to not let neither side of the patch to come in direct contact with skin and to never adhere patch directly to bare skin.No complaint sample was received for investigation at responsible quality unit (rqu).Investigation of reported batch records and retained samples was conducted and the outcome of the investigation resulted in an unconfirmed quality defect.Therefore there is no reason to suspect a causal relationship between the reported medical events and a quality defect.The complaint was deemed to have occurred due to user handling error of device.This complaint is subject to routine signaling, trending according to established procedures.Any need for a corrective and/or preventive action is determined in response to the respective signal.Most recent follow-up information incorporated above includes: on 2-mar-2023: all required follow-up attempts were completed by company.Thermal burn ("i discovered severe burns under the patch after removing it from my skin"), application site pain and application site wound are unlisted in the reference safety information of midol heat vibes (no active ingredient) while wrong technique in device usage process is listed.Given that the patient used the product in a wrong way, plus, the strong temporal relation, causality between the events and the product cannot be excluded at the time (related).Based on the available information, a review of our complaint records and other relevant data was conducted (unconfirmed quality defect); any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

• Brand Name: MIDOL HEAT VIBES
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): WOOSHIN LABOTTACH CO., LTD.; 1907, daerung post tower i; 288; guro-dong, guro-gu, seoul 152-0 50; KS 152-050
• MDR Report Key: 16311427
• MDR Text Key: 308934839
• Report Number: 3000206585-2023-00002
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/03/2023

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: Lay User/Patient
• Device Expiration Date: 04/03/2024
• Device Lot Number: BU22172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2023
• Distributor Facility Aware Date: 03/02/2023
• Date Report to Manufacturer: 03/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/09/2023; 02/23/2023; 02/28/2023; 03/03/2023
• Patient Sequence Number: 1
• Treatment: AMLODIL [AMLODIPINE].; AMLODIL [AMLODIPINE].; AMLODIL [AMLODIPINE].; AMLODIL [AMLODIPINE].; CETIRIZINE.; CETIRIZINE.; CETIRIZINE.; CETIRIZINE.; ESCITALOPRAM.; ESCITALOPRAM.; ESCITALOPRAM.; ESCITALOPRAM.; LISINOPRIL.; LISINOPRIL.; LISINOPRIL.; LISINOPRIL.
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Female