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

Lot Number BU23052

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)

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 ("i used your midol heat vibes on my back and the product burned me.") and burns second degree ("big blister at my back") in a 48 year-old female patient who received midol heat vibes medicated plaster (lot no.Bu23052) for pain.Product or product use issues identified: wrong technique in device usage process ("the patch was applied directly to the skin.").Medical conditions: the consumer refused to provide a relevant medical history.On an unknown date, the patient started midol heat vibes one patch medical device for 5 hours.On unknown dates she experienced thermal burn (seriousness criterion medically important) and burns second degree (seriousness criterion medically important).Midol heat vibes was withdrawn.At the time of the report, the thermal burn and burns second degree had not resolved.The reporter considered burns second degree and thermal burn to be related to midol heat vibes administration.The reporter commented: other medications was not discussed.The exact place at the back was not confirmed - attempted to call back the consumer but the line was busy.The patch was applied for 5 hours.The most recent follow-up information incorporated above includes data received on: 15-feb-2024: new event "the patch was applied directly to the skin".We received a lot number in this case.A technical investigation will be 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.

Event Description

Bayer case number:(b)(4).This spontaneous case was reported by a consumer and describes the occurrence of thermal burn ("i used your midol heat vibes on my back and the product burned me.") and burns second degree ("big blister at my back") in a 48 year-old female patient who received midol heat vibes medicated plaster (lot no.Bu23052) for pain.Product or product use issues identified: wrong technique in device usage process ("the patch was applied directly to the skin.").Medical conditions: the consumer refused to provide a relevant medical history.On an unknown date, the patient started midol heat vibes one patch medical device medical device over 5 hours.On unknown dates she experienced thermal burn (seriousness criterion medically important) and burns second degree (seriousness criterion medically important).Midol heat vibes was withdrawn.At the time of the report, the thermal burn and burns second degree had not resolved.The reporter considered burns second degree and thermal burn to be related to midol heat vibes administration.The reporter commented: other medications was not discussed.The exact place at the back was not confirmed - attempted to call back the consumer but the line was busy.The patch was applied for 5 hours.Batch no.Bu23052, production date:2023-05-24, expiration date:2025-05-23.Quality-safety evaluation of ptc: for midol heat vibes: no complaint sample was received for investigation at responsible quality unit (rqu).Based on the available information, no product quality defect was 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: 20-mar-2024: quality safety evaluation of ptc was received.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.

• 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: 18730172
• MDR Text Key: 335744113
• Report Number: 3000206585-2024-00004
• 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
• Report Date: 03/20/2024

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
• Device Lot Number: BU23052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/20/2024
• Distributor Facility Aware Date: 03/20/2024
• Date Report to Manufacturer: 03/20/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Female