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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Excessive Heating (4030)

Patient Problem Burn(s) (1757)

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 look and there is my skin burnt off") in a patient who received midol heat vibes medicated plaster (lot no.Unkunknown).Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On an unknown date, the patient started midol heat vibes (topical) i applied it to the inside of my clothing.On unknown dates the patient experienced thermal burn (seriousness criterion medically important) and application site pain ("i used the midol heat vibes and felt something stinging on my stomach /my stomach i was in pain").It was unknown whether any action was taken with midol heat vibes.At the time of the report, the outcomes for these events were unknown.The reporter considered application site pain and thermal burn to be related to midol heat vibes administration.The reporter commented: a consumer of unknown gender and age (at least 18 years old: yes) stated: "i used the midol heat vibes and felt something stinging on my stomach.I applied it to the inside of my clothing as said on package and when i went to check my stomach i was in pain i look and there is my skin burnt off.I am not sure what can be done about this but i am thinking if i should get a lawyer or not i am a firm user of midol products and this is really dissapointing to have went through.".The most recent follow-up information incorporated above includes data received on: (b)(6) 2023: processed with the initial report.(b)(6) 2023: processed with the initial report.(b)(6) 2023: processed with the initial report.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 thermal burn ("i look and there is my skin burnt off") in a patient who received midol heat vibes medicated plaster (lot no.Unkunknown).Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On an unknown date, the patient started midol heat vibes (topical) i applied it to the inside of my clothing.On unknown dates the patient experienced thermal burn (seriousness criterion medically important) and application site pain ("i used the midol heat vibes and felt something stinging on my stomach /my stomach i was in pain").It was unknown whether any action was taken with midol heat vibes.At the time of the report, the outcomes for these events were unknown.The reporter considered application site pain and thermal burn to be related to midol heat vibes administration.The reporter commented: a consumer of unknown gender and age (at least 18 years old: yes) stated: "i used the midol heat vibes and felt something stinging on my stomach.I applied it to the inside of my clothing as said on package and when i went to check my stomach i was in pain i look and there is my skin burnt off.I am not sure what can be done about this but i am thinking if i should get a lawyer or not i am a firm user of midol products and this is really disappointing to have went through.".Quality-safety evaluation of ptc: for midol heat vibes: 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.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.The most recent follow-up information incorporated above includes data received on: 06-jul-2023: pqs: addition of quality-safety evaluation of ptc, update of global ptc number, pdf attached, ticked final report, updated imdrf codes, updated eu/ca and mir tabs.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.Ptc investigation result: 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.

• 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: 17134743
• MDR Text Key: 317226833
• Report Number: 3000206585-2023-00005
• 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
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2023
• Distributor Facility Aware Date: 07/06/2023
• Date Report to Manufacturer: 07/07/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other