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); Insufficient Information (3190)

Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)

Event Date 01/25/2024

Event Type  Injury  

Event Description

Bayer case number: (b)(4).This spontaneous case was reported by a consumer through social media and describes the occurrence of thermal burn ("it burned a chunk of my skin off.I used it as directed and it still burned a good 2 inches of skin.") in a female patient who received midol heat vibes medicated plaster (lot no.Unkunknown).Medical conditions: patient's relevant history and another medication was not discussed.On an unknown date, the patient started midol heat vibes at an unspecified dose and frequency.On an unknown date she experienced thermal burn (seriousness criterion medically important).It was unknown whether any action was taken with midol heat vibes.At the time of the report, the outcome of the event was unknown.The reporter considered thermal burn to be related to midol heat vibes administration.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 through social media and describes the occurrence of burns second degree ("it burned a chunk of my skin off.I used it as directed and it still burned a good 2 inches of skin, the midol heat vibe patch gave me a second degree burn") in a 38 year-old female patient who received midol heat vibes medicated plaster (lot no: unknown).Medical conditions: patient's relevant history and another medication was not discussed.From on (b)(6) 2024, the patient received midol heat vibes at an unspecified dose and frequency.On (b)(6) 2024, 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vibes initiation, she experienced burns second degree (seriousness criterion medically important).Midol heat vibes was withdrawn.At the time of the report, the event was resolving.The reporter considered burns second degree to be related to midol heat vibes administration.The reporter commented: action taken: drug withdrawn.The midol heat vibes were discontinued when i discovered the burn, which is still healing.I just went to the doctor yesterday to have it checked out again.The doctor had to freeze the scab off, which had hardened into a very thick tissue, keeping it from healing in the center of the burn wound.Hopefully now it will continue to heal.My stomach is finally almost healed, after nearly three months since the midol heat vibe patch gave me a second degree burn.Quality-safety evaluation of ptc: for midol heat vibes: an in-depth ptc investigation cannot be conducted by the quality unit as neither a batch number nor sample was provided.A quality defect could not be confirmed.Therefore there is no reason to suspect a causal relationship between the reported events and a quality defect.The reported events are not indicative of a quality deficit 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.The most recent follow-up information incorporated above includes data received on: 16-apr-2024: "it burned a chunk of my skin off.I used it as directed and it still burned a good 2 inches of skin" updated to "it burned a chunk of my skin off.I used it as directed and it still burned a good 2 inches of skin, the midol heat vibe patch gave me a second degree burn".Description to be coded was updated from "thermal burn" to "second degree burn".16-apr-2024: no new information was added.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 could not confirm a quality defect.

Event Description

Bayer case number: (b)(4).This spontaneous case was reported by a consumer through social media and describes the occurrence of thermal burn ("it burned a chunk of my skin off.I used it as directed and it still burned a good 2 inches of skin.") in a 38 year-old female patient who received midol heat vibes medicated plaster (lot no.Unknown).Medical conditions: patient's relevant history and another medication was not discussed.From (b)(6) 2024 to (b)(6) 2024, the patient received midol heat vibes at an unspecified dose and frequency.On (b)(6) 2024, the day of midol heat vibes initiation, she experienced thermal burn (seriousness criterion medically important).It was unknown whether any action was taken with midol heat vibes.At the time of the report, the event was resolving.The reporter considered thermal burn to be related to midol heat vibes administration.The reporter commented: action taken: drug withdrawn.Quality-safety evaluation of ptc: for midol heat vibes: an in-depth ptc investigation cannot be conducted by the quality unit as neither a batch number nor sample was provided.A quality defect could not be confirmed.Therefore there is no reason to suspect a causal relationship between the reported events and a quality defect.The reported events are not indicative of a quality deficit 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.The most recent follow-up information incorporated above includes data received on: 07-feb-2024: patent demographics date of birth and age was added.Reporter information was added.Start and stop date of drug was added.For the event thermal burn start date and outcome was added.07-feb-2024: addition of quality-safety evaluation of ptc: update of global ptc number, pdf attached, ticked final report, update of imdrf codes and eu/ca tab.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: 18649588
• MDR Text Key: 334629148
• Report Number: 3000206585-2024-00003
• 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
• Report Date: 04/22/2024

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/22/2024
• Distributor Facility Aware Date: 04/16/2024
• Date Report to Manufacturer: 04/22/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/12/2024; 04/22/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Sex: Female