MAUDE Adverse Event Report: WOOSHIN LABOTTACH CO., LTD. MIDOL HEAT VIBES; PACK, HOT OR COLD, DISPOSABLE

Device Problems Insufficient Information (3190); Excessive Heating (4030)

Patient Problems Burn(s) (1757); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

Bayer case number: (b)(4).This patient was identified during a market research program.The patient received midol heat vibes (batch no.Unk) for menstrual cramps.The case describes the occurrence of thermal burn ('skin burns'), blister ('i noticed some blisters on my skin') and blister rupture ('two days later these blisters burst').The occurrence of additional non-serious events is detailed below.On an unknown date, the patient started midol heat vibes.On an unknown date, the patient experienced thermal burn (seriousness criterion medically significant), blister (seriousness criterion medically significant), blister rupture (seriousness criterion medically significant) and skin lesion inflammation ("i now have this inflamed wound on my skin.").It was unknown whether any action was taken with midol heat vibes.At the time of the report, the thermal burn, blister, blister rupture and skin lesion inflammation outcome was unknown.The reporter considered blister, blister rupture, skin lesion inflammation and thermal burn to be related to midol heat vibes.Quality-safety evaluation of ptc: 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.Most recent follow-up information incorporated above includes: on 27-jul-2022: quality-safety evaluation of ptc.Amendment: the report was also amended for the following reason: upon an internal review, the event "thermal burn" were added to the case.Event "rash vesicular " was updated to "blister rupture".Case upgrade to serious-incident.Imdrf codes updated.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)(64) this patient was identified during a market research program.The patient was given midol heat vibes (lot no.Unkunknown) for menstrual cramps.The case describes the occurrence of thermal burn ("skin burns"), blister ("i noticed some blisters on my skin") and blister rupture ("two days later these blisters burst").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 thermal burn (seriousness criterion medically important), blister (seriousness criterion medically important), blister rupture (seriousness criterion medically important) and skin lesion inflammation ("i now have this inflamed wound on my skin.").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, blister rupture, skin lesion inflammation 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: 24-aug-2022: quality-safety evaluation of ptc.Annex a updated.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 patient was identified during a market research program.The patient received midol heat vibes (batch no.Unk) for menstrual cramps.The case describes the occurrence of thermal burn ('skin burns'), blister ('i noticed some blisters on my skin') and blister rupture ('two days later these blisters burst').The occurrence of additional non-serious events is detailed below.On an unknown date, the patient started midol heat vibes.On an unknown date, the patient experienced thermal burn (seriousness criterion medically significant), blister (seriousness criterion medically significant), blister rupture (seriousness criterion medically significant) and skin lesion inflammation ("i now have this inflamed wound on my skin.").It was unknown whether any action was taken with midol heat vibes.At the time of the report, the thermal burn, blister, blister rupture and skin lesion inflammation outcome was unknown.The reporter considered blister, blister rupture, skin lesion inflammation and thermal burn to be related to midol heat vibes.Quality-safety evaluation of ptc: 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.Most recent follow-up information incorporated above includes: on 30-aug-2022: all required attempt were completed by company.Update to initial was ticked.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.

• 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: 15128690
• MDR Text Key: 296850807
• Report Number: 3000206585-2022-00001
• 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,Followup
• Report Date: 09/01/2022

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: 09/01/2022
• Distributor Facility Aware Date: 08/30/2022
• Date Report to Manufacturer: 08/31/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/25/2022; 09/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other