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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WOOSHIN LABOTTACH CO., LTD. MIDOL HEAT VIBES; PACK, HOT OR COLD, DISPOSABLE
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WOOSHIN LABOTTACH CO., LTD. MIDOL HEAT VIBES; PACK, HOT OR COLD, DISPOSABLE Back to Search Results
Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
Patient Problems Burn(s) (1757); Blister (4537)
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 ("the next day i find a burn mark in that area") and blister ("it has burned so bad i have a blister.") in a patient who received midol heat vibes medicated plaster (lot no.Unknown).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 thermal burn (seriousness criterion medically important) with medical device site pain and blister (seriousness criterion medically important).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 blister and thermal burn to be related to midol heat vibes administration.Further company follow-up with the reporter is not possible.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 thermal burn ("the next day i find a burn mark in that area") and blister ("it has burned so bad i have a blister.") in a patient who received midol heat vibes medicated plaster (lot no.Unkunknown).Product or product use issues identified: device use error ("it was enough to get some comfort relax/nap").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 thermal burn (seriousness criterion medically important) with medical device site pain and blister (seriousness criterion medically important).It was unknown whether any action was taken with midol heat vibes.At the time of the report, the outcomes for thermal burn and blister were unknown.The reporter considered blister and 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: 02-dec-2022: quality-safety evaluation of ptc.New event device use error was added.Further company follow-up with the consumer or the reporter is not possible.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.
 
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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 Key15436818
MDR Text Key300034705
Report Number3000206585-2022-00003
Device Sequence Number1
Product Code IMD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2022
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 FDA12/06/2022
Distributor Facility Aware Date12/02/2022
Date Report to Manufacturer12/06/2022
Patient Sequence Number1
Patient Outcome(s) Other;
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