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); Insufficient Information (3190)

Patient Problem Burn(s) (1757)

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 ("midol heat vibes patch burned my stomach") in a female patient who received midol heat vibes medicated plaster.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 she experienced thermal burn (seriousness criterion medically important), skin exfoliation ("took skin off") and skin haemorrhage ("it's bleeding").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 skin exfoliation, skin haemorrhage and thermal burn to be related to midol heat vibes administration.The reporter commented: midol heat vibes patch burned stomach and took skin off and it's bleeding.The following amendment was made: the event: "midol heat vibes patch burned my stomach " was updated, and considered a serious incident.No new follow-up information was received from the reporter.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 and describes the occurrence of thermal burn ("midol heat vibes patch burned my stomach") in a female patient who received midol heat vibes medicated plaster.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 she experienced thermal burn (seriousness criterion medically important), skin exfoliation ("took skin off") and skin haemorrhage ("it's bleeding").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 skin exfoliation, skin haemorrhage and thermal burn to be related to midol heat vibes administration.The reporter commented: midol heat vibes patch burned stomach and took skin off and it's bleeding.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: 14-nov-2022: quality-safety evaluation of ptc: unconfirmed quality defect, ptc global number added, updated of codes and mir form.On 11-nov-2022: no new clinical information received.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.

• 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: 15641826
• MDR Text Key: 302117443
• Report Number: 3000206585-2022-00004
• 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: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• 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 FDA: 11/21/2022
• Distributor Facility Aware Date: 11/14/2022
• Date Report to Manufacturer: 11/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female