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 Problem Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

Bayer case number: (b)(4).This spontaneous case was reported by a consumer and describes the occurrence of burns second degree ("burned my skin, blistered") in a patient who received midol heat vibes medicated plaster for pain and muscle spasms.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 at an unspecified dose and frequency.On unknown dates the patient experienced burns second degree (seriousness criterion medically important) and pain ("pain").It was unknown whether any action was taken with midol heat vibes.The reporter considered burns second degree and pain to be related to midol heat vibes administration.The reporter commented: i recently bought these pads for my cramps.Ive been using them for over a year, however, this batch burned my skin.It has never happened before i put it on for about 4 hours and decided to remove it for the night which was (b)(6).The following morning i woke up and felt pain and realized it was a burn, blistered, and popped.And its in an area where its being touched daily so it wont heal.Ive had to miss some work because of the pain.At least 18 years old.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 ("burned my skin, blistered") in a patient who received midol heat vibes medicated plaster for pain and muscle spasms.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 at an unspecified dose and frequency.On unknown dates the patient experienced burns second degree (seriousness criterion medically important) and pain ("pain").It was unknown whether any action was taken with midol heat vibes.The reporter considered burns second degree and pain to be related to midol heat vibes administration.The reporter commented: i recently bought these pads for my cramps.Ive been using them for over a year, however, this batch burned my skin.It has never happened before i put it on for about 4 hours and decided to remove it for the night which was 12/31.The following morning i woke up and felt pain and realized it was a burn, blistered, and popped.And its in an area where its being touched daily so it wont heal.Ive had to miss some work because of the pain.At least 18 years old.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 event and a quality defect.The reported event is 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-jan-2024: quality safety evaluation of ptc.Unconfirmed quality defect.Ptc global number, addition of batch and pdf of ptc result.We received a batch number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report quality-safety evaluation of ptc: unconfirmed quality defect.

• 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: 18465485
• MDR Text Key: 332323232
• Report Number: 3000206585-2024-00001
• 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: 01/23/2024

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
• 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: 01/23/2024
• Distributor Facility Aware Date: 01/16/2024
• Date Report to Manufacturer: 01/19/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/23/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other