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

Lot Number BU22011

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 12/19/2022

Event Type  Injury  

Event Description

Bayer case number : (b)(4).This 34-year-old female patient was identified during a market research program.The patient was given midol heat vibes.The case describes the occurrence of burns second degree ("blistered burn on my abdomen").There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2022 the patient received midol heat vibes 1df once.On (b)(6) 2022, the day of midol heat vibes initiation, she experienced burns second degree (seriousness criterion medically important).Midol heat vibes was withdrawn.At the time of the report, the event had not resolved.The reporter considered burns second degree to be related to midol heat vibes administration.The reporter commented: that used the midol heat vibes patch for the first time yesterday (b)(6) 2022 and followed the instructions, however, had a blistered burn on abdomen.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 burns second degree ('blistered burn on my abdomen') in a 34-year-old female patient who received midol heat vibes medicated plaster.On an unknown date, the patient started midol heat vibes.On 19-dec-2022, the patient experienced burns second degree (seriousness criterion medically significant).At the time of the report, the burns second degree had not resolved.The reporter considered burns second degree to be related to midol heat vibes.The reporter commented: that used the midol heat vibes patch for the first time yesterday 19-dec-22 and followed the instructions, however, had a blistered burn on abdomen.Amendment: the report was amended for the following reason: changed the reporter type from study to spontaneous and delete the study reference number.No new follow-up information was received from the reporter.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 burns second degree ('blistered burn on my abdomen') in a 34-year-old female patient who received midol heat vibes medicated plaster (batch no.Bu22011) for pain.On an unknown date, the patient started midol heat vibes, used 1 pacth only.On (b)(6) 2022, the patient experienced burns second degree (seriousness criterion medically significant).Midol heat vibes was withdrawn.On (b)(6) 2022, the burns second degree had resolved.The reporter considered burns second degree to be related to midol heat vibes.The reporter commented: that used the midol heat vibes patch for the first time yesterday (b)(6) 2022 and followed the instructions, however, had a blistered burn on abdomen most recent follow-up information incorporated above includes: on (b)(6) 2023: event "blistered burn on my abdomen" stop date and outcome was added.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 burns second degree ('blistered burn on my abdomen') in a 34-year-old female patient who received midol heat vibes medicated plaster (batch no.Bu22011) for pain.On an unknown date, the patient started midol heat vibes.On (b)(6) 2022, the patient experienced burns second degree (seriousness criterion medically significant).Midol heat vibes was withdrawn.On (b)(6) 2022, the burns second degree had resolved.The reporter considered burns second degree to be related to midol heat vibes.The reporter commented: that used the midol heat vibes patch for the first time yesterday (b)(6) 2022 and followed the instructions, however, had a blistered burn on abdomen.Quality-safety evaluation of ptc: based on technical investigation, the batch record and retained samples for batch bu22011 were reviewed and no deviations or nonconformances were found.The average temperature of the retain sample is 53.4 c which is within the specified criteria (50-60 c).It is possible that, according to the picture received, the cause of the burn could be the result of the patch being in direct contact with the skin.No complaint sample was received for investigation at responsible quality unit (rqu).Investigation of provided photos, reported batch records and retained sample 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 reported medical events are not indicative of a quality defect per se.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 8-feb-2023: fu12 & fu13 process together, all required attempt were completed by company, case closure, update to initial report (follow-up report) was ticked, on 9-feb-2023: fu12 & fu13 process together, quality-safety evaluation of ptc, unconfirmed quality defect, update of global ptc number, eu/ca and eu mir fields updated, final report ticked.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.

• 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: 16042842
• MDR Text Key: 306084718
• Report Number: 3000206585-2022-00005
• 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
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/04/2024
• Device Lot Number: BU22011
• 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: 02/23/2023
• Distributor Facility Aware Date: 02/08/2023
• Date Report to Manufacturer: 02/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Sex: Female