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 family member and describes the occurrence of thermal burn ("it left her with a burn") in a female patient who received midol heat vibes medicated plaster (lot no.Unkunknown).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 most recent follow-up information incorporated above includes data received on: 10-jun-2023: no new information was received.12-jun-2023: no new information was received.12-jun-2023: no new information was received.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 family member and describes the occurrence of thermal burn ("it left her with a burn") in a female patient who received midol heat vibes medicated plaster (lot no.Unkunknown).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: 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: 05-jul-2023: quality-safety evaluation of ptc: unconfirmed quality defect, ptc global number was added, final report was ticked, eu/ca and mir tabs and imdrf codes updated.07-jul-2023: all required attempt were completed.Case closed.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.

Event Description

Bayer case number: (b)(4).This spontaneous case was reported by a family member and describes the occurrence of thermal burn ("it left her with a burn") in a female patient who received midol heat vibes medicated plaster (lot no.Unkunknown).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: 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: 12-sep-2023: all required attempt were completed by company.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.Thermal burn (listed) is deemed related to company product, as this product provides heat therapy, therefore burn related adverse events are common.

• 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: 17133907
• MDR Text Key: 317220539
• Report Number: 3000206585-2023-00004
• 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: 09/15/2023

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: 09/15/2023
• Distributor Facility Aware Date: 09/12/2023
• Date Report to Manufacturer: 09/15/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female