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 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 ("this product burned me through my clothes") in a female patient who received midol heat vibes medicated plaster.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 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.The following amendment was made: upon bayer internal review event "this product burned me through my clothes" pt was updated from "application site burn" to "thermal burn".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 thermal burn ("this product burned me through my clothes") in a female patient who received midol heat vibes medicated plaster.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 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.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: 11-mar-2024: quality-safety evaluation of ptc was received.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: 18873880
• MDR Text Key: 337305911
• Report Number: 3000206585-2024-00005
• 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: 03/13/2024

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: 03/13/2024
• Distributor Facility Aware Date: 03/11/2024
• Date Report to Manufacturer: 03/13/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/13/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female