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

Lot Number BU23038

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/04/2023

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 ("these are serious burns that will likely leave marks on my body forever") in a 24 year-old female patient who received midol heat vibes medicated plaster (lot no.Bu23038) for pain.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 one patch over 7 days.On unknown dates she experienced thermal burn (seriousness criterion medically important), application site erythema ("i had it on for like 3 hours, and my stomach was red"), application site scar ("now i have a scar.My stomach is gonna have a scar.") and application site irritation ("my stomach is gonna have a scar.It is very irritating,").Midol heat vibes was withdrawn.At the time of the report, the application site erythema, application site scar and application site irritation had not resolved.The reporter considered application site erythema, application site irritation and application site scar to be related to midol heat vibes administration.No causality assessment was received for midol heat vibes with regard to thermal burn.The most recent follow-up information incorporated above includes data received on: 14-dec-2023: new event "these are serious burns that will likely leave marks on my body forever" was added.21-dec-2023: this case is found to be duplicate case of (b)(4) case.All required data are transferred from (b)(4) case to (b)(4) case.No new information was added.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 medical device site burn ("these are serious burns that will likely leave marks on my body forever") in a 24 year-old female patient who received midol heat vibes medicated plaster (lot no.Bu23038) for pain.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 one patch over 7 days.On unknown dates she experienced medical device site burn (seriousness criterion medically important), application site erythema ("i had it on for like 3 hours, and my stomach was red"), application site scar ("now i have a scar.My stomach is gonna have a scar.") and application site irritation ("my stomach is gonna have a scar.It is very irritating,").Midol heat vibes was withdrawn.At the time of the report, the application site erythema, application site scar and application site irritation had not resolved.The reporter considered application site erythema, application site irritation and application site scar to be related to midol heat vibes administration.No causality assessment was received for midol heat vibes with regard to medical device site burn.The reporter commented: i had it on for like 3 hours, and my stomach was red, and now i have a scar.My stomach is gonna have a scar.It is very irritating, i have pictures.This is unbelievable.Batch no bu23038 production date (b0(6) 2023, expiration date 2025-05-11.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: 02-jan-2024: quality safety evaluation of ptc.Unconfirmed quality defect.Ptc global number added, batch information (expiration and manufacture dates) added, final report ticket, imdrf codes added,.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.

Event Description

Bayer case number: (b)(4).This spontaneous case was reported by a consumer and describes the occurrence of medical device site burn ("these are serious burns that will likely leave marks on my body forever") and burns second degree ("burns were conducive to 2nd degree burns, due to the burns filling with puss and the level of thickness they were at.") in a 24 year-old female patient who received midol heat vibes medicated plaster (lot no.Bu23038) for pain.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 one patch over 7 days.On (b)(6) 2023 she experienced medical device site burn (seriousness criterion medically important).On unknown dates she experienced burns second degree (seriousness criterion medically important), application site erythema ("i had it on for like 3 hours, and my stomach was red"), application site scar ("now i have a scar.My stomach is gonna have a scar."), application site irritation ("my stomach is gonna have a scar.It is very irritating,"), purulent discharge ("burns were conducive to 2nd degree burns, due to the burns filling with puss and the level of thickness they were at.") and application site pain ("i suffered a great deal of pain and could not shower due to the pain").Midol heat vibes was withdrawn.At the time of the report, the medical device site burn, application site erythema, application site scar and application site irritation had not resolved.The reporter considered application site erythema, application site irritation, application site pain and application site scar to be related to midol heat vibes administration.No causality assessment was received for midol heat vibes with regard to medical device site burn, burns second degree or purulent discharge.The reporter commented: i had it on for like 3 hours, and my stomach was red, and now i have a scar.My stomach is gonna have a scar.It is very irritating, i have pictures.This is unbelievable.I was severely burned by a midol heat patch.I had the patch on for 2-3 hours over a tank top.The patch has left me with several hideous burns that have now scarred.I had to miss three days of work because i could not put pants or anything on my stomach because of the irritation.When speaking to the doctor she stated that the burns were conducive to 2nd degree burns, due to the burns filling with puss and the level of thickness they were at.At my next appointment, i will be given a plan on how long it will take them to be removed if they can be.This has severely impacted my confidence having these dark scars on my body.As far as compensation goes for the missed hours of work, not being able to shower because of the pain, doctors appointments, prescription, and scar removal, as well as it being conducive to a 2nd degree burns.Batch no bu23038, production date 2023-05-12, expiration date 2025-05-11.Quality-safety evaluation of ptc: for midol heat vibes: based on technical investigation no deviations or nonconformances were noted during the review of the batch records or coa.All in-process inspections, manufacturing requirement and final testing of the product met the release specification.The consumer provided photographs of the scars they experienced in which they report were a result of using midol heat vibes.After examining the photographs, it is not clear on which type of clothing material it was attached to.Certain fabrics or materials might affect the patch's ability to deliver its intended benefits.This is inconclusive since the review of records and retained samples does not provide evidence to support a defective product.The complaint sample was received in morristown.Two opened pouches were returned.One pouch contained a used midol heat vibes patch.No anomalies were present on the complaint sample.Device testing is not possible as the samples were received open and activated.Retain sample was visually inspected no anomalies were found.The temperature of the retain sample after activation was within the specified range (50-60 c).A retain sample was applied to the abdomen of 5 individuals for over 8 hours, no skin abnormalities were observed.Investigation of reported batch records, retained sample, provided photos as well as complaint sample was conducted, and the outcome of the investigation resulted in an unconfirmed quality defect due to lack of detailed information, such as the type of clothing worn during the patch application and whether it was used during sleep.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: 04-feb-2024: event start date and outcome "not recovered / not resolved" for event "these are serious burns that will likely leave marks on my body forever" was added.(b)(6) 2024: new events "second degree burns, purulent discharge and application site pain" were added.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: 18387117
• MDR Text Key: 331293464
• Report Number: 3000206585-2023-00013
• 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: 02/09/2024

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: BU23038
• 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: 02/09/2024
• Distributor Facility Aware Date: 02/04/2024
• Date Report to Manufacturer: 02/05/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/04/2024; 02/09/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR
• Patient Sex: Female