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

Lot Number BU21004

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190); Excessive Heating (4030)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 07/04/2022

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 stomach / left second degree burns on me') in a 31-year-old female patient who received midol heat vibes medicated plaster (batch no.Bu21004) for pain.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient started midol heat vibes.On (b)(6) 2022, the patient experienced burns second degree (seriousness criterion medically significant) and experienced medical device site pain ("pain from the burns"), 1 day after starting midol heat vibes.At the time of the report, the burns second degree and medical device site pain had not resolved.The reporter considered burns second degree and medical device site pain to be related to midol heat vibes.The reporter commented: they left second degree burns on me and i didnt place them directly on my skin.Most recent follow-up information incorporated above includes: on (b)(6) 2022: case (b)(4) was deleted from bayer's database as it was a follow-up for this case.Follow-up: the event "thermal burn" was updated to "second degree burn".On (b)(6) 2022: no new information was received.On (b)(6) 2022: follow up processed together.On (b)(6) 2022: follow up processed together.On (b)(6) 2022: follow up processed together.On (b)(6) 2022: date of birth of patient was added; product indication was added.On (b)(6) 2022: follow up processed together.On (b)(6) 2022: follow up processed together.Amendment: the report was also amended for the following reason: upon an internal review, case upgrade to serious-incident.Imdrf codes updated.A technical investigation was conduct, 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.

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 stomach / left second degree burns on me') in a 31-year-old female patient who received midol heat vibes medicated plaster (batch no.Bu21004) for pain.The occurrence of additional non-serious events is detailed below.(b)(6) 2022, the patient received midol heat vibes at an unspecified dose and frequency.On (b)(6) 2022, the patient experienced burns second degree (seriousness criterion medically significant) and medical device site pain ("pain from the burns").At the time of the report, the burns second degree and medical device site pain had not resolved.The reporter considered burns second degree and medical device site pain to be related to midol heat vibes.The reporter commented: they left second degree burns on me and i didnt place them directly on my skin most recent follow-up information incorporated above includes: on 22-aug-2022: all required attempt were completed by company.Update to initial was ticked.On 22-aug-2022: product start and stop date updated.A technical investigation was conduct, 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.

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 stomach / left second degree burns on me") in a 31 year-old female patient who received midol heat vibes medicated plaster (lot no.Bu21004) for pain.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.From (b)(6) 2022 the patient received midol heat vibes at an unspecified dose and frequency.On (b)(6) 2022, the day of midol heat vibes initiation, she experienced burns second degree (seriousness criterion medically important) and medical device site pain ("pain from the burns").At the time of the report, none of the events had resolved.The reporter considered burns second degree and medical device site pain to be related to midol heat vibes administration.The reporter commented: they left second degree burns on me and i didnt place them directly on my skin.The most recent follow-up information incorporated above includes data received on: 26-sep-2022: all required attempt were completed by company, update to initial report was ticked in device tab.30-sep-2022: fda code synchronization.07-oct-2022: fda codes synchronization.10-oct-2022: fda code synchronization.A technical investigation was 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.Ptc investigation result: no complaint sample was received for investigation by responsible quality unit (rqu).The investigation of batch records and retained sample was conducted and the outcome resulted in an 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: 15155607
• MDR Text Key: 297142100
• Report Number: 3000206585-2022-00002
• 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: 10/10/2022

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
• Device Lot Number: BU21004
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2022
• Distributor Facility Aware Date: 09/19/2022
• Date Report to Manufacturer: 09/20/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/25/2022; 10/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Sex: Female