MAUDE Adverse Event Report: BRIDGES CONSUMER HEALTHCARE THERMACARE NECK/SHOULDER/WRIST; PACK, HOT OR COLD, DISPOSABLE

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

Patient Problems Burn(s) (1757); Superficial (First Degree) Burn (2685)

Event Date 01/29/2024

Event Type  Injury  

Event Description

This initial, solicited report from italy was received on (b)(6)2024 via email on behalf of a female consumer of unknown age.Medical history included muscle tension, although further medical histoy was unspecified.No allergy information was specified.Concomitant medical products included unspecified oral medications.On an unspecified date, the consumer applied thermacare neck shoulder wrist 12-hour (lot number and expiration date unknown) to her neck for chronic muscle tension for approximately 24-48 hours.She applied the heat wrap to her clothing citing that the heat was very intense.After wearing the heat wrap for approximately four to six hours, she developed burns on 29-jan-2024.She also noted that she took unspecified oral medication during the time that the heat wrap was in place.No further clinical details were provided.The outcomes of thermal burn and intentional device misuse were unknown.The action taken with the device was also unknown.No further information was available.Meddra coding thermal burn s/exp intentional device misuse ns/unex.

Manufacturer Narrative

Follow up received on (b)(6) 2024 from qa department.Complaint number ((b)(4)) this investigation was conducted for an unknown batch of nsw product.There was limited device specific information provided.No batch number was available for evaluation.Without a batch reference number, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.A 36-month trend analysis has been conducted, the records search returned a total of 13 complaints for nsw 12hr products during this time period.Four of the 13 were not identified as 8 or 12 hour product.The search described in this investigation summary takes into consideration all adverse events.There were no complaints confirmed to have a manufacturing related process root cause for a complaint of adverse event safety request for investigation.There is not a trend identified for the subclass of adverse event safety request for investigation for thermacare nsw product.There is no further action required.Considering the current information available for this complaint it is not possible to determine a root cause.However, there are pre-identified risk factors that could cause skin burns in the hazard analysis (rpt-000097160).There are mitigations in place to prevent these situations such as in-process testing, thermal testing and visual inspections to ensure the quality and safety of the product.There are also multiple risks that are outside the control of the site.These include things like age, skin condition, medical conditions, device use error and off label use.The warning labels on our product are used to address these risks and relay the appropriate instructions for use to our customers to avoid burns, blisters and skin irritations.There are pre-identified risk factors that could cause a burn listed in the hazard analysis (rpt-000097160).During the investigation of this complaint rpt-000097160 was reviewed and no further risk was identified.Since this complaint is not justified and there is no identified defect, there is no change needed to the risk documentation as a result of this investigation.Based on the information provided, the event of thermal burn as described in this case is considered serious bodily injury potentially requiring medical intervention to prevent permanent damage or impairment of body structure, assessed as associated with the intentional device misuse.The pi of thermacare neck shoulder wrist 12 hour mentions that thermal burn could be an adverse event of this medical device, whereas it does not mention intentional device misuse.Dechallenge and rechallenge were unknown.Temporal association adverse events-medical device is plausible.Based on the information provided, the causal relationship between thermacare neck shoulder wrist 12 hour and the reported adverse event thermal burn was considered as possible, for intentional device misuse it was considered not assessable.This investigation was conducted for an unknown batch number of nsw 12hr with the sub class adverse event safety request for investigation.There was limited device specific information provided.Without a valid batch reference number, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.The complaint was evaluated to identify any potential trends.A 36-month trend analysis will be conducted for complaints with an unknown batch number since the date of manufacture is unknown for unknown batch numbers.There is not a trend identified.There is no further action required.The most probable root cause cannot be identified.

Event Description

Angelini s.P.A.Provided additional information regarding the report to bridges consumer healthcare on (b)(6) 2024.Angelini s.P.A.Received the information on (b)(6) 2024.The information verbatim is as follows: this serious solicited case, manufacturer control number (b)(4) is an initial report from italy received on (b)(6) 2024 from a consumer through italymdvigilance via market survey ((b)(4)).This case report concerns a female patient, who applied thermacare neck shoulder wrist (batch: unknown; expiry date: unknown) for muscle tension.Concomitant medication(s): unspecified oral medications medical history: past use of thermacare.On unknown date, after thermacare neck shoulder wrist 12 hour initiation, the patient [experienced thermal burn, intentional device misuse.The consumer stated that she applied thermacare to her neck (for chronic muscle tension for 3 months) during the day for 1-2 days.The consumer applied the patches on her clothes because the heat was very strong and after 4-6 hours she developed burns.During the period, when she had the symptoms, she also took oral medications in addition to using the thermacare device.Outcome: thermal burn : unknown, intentional device misuse : unknown.The action taken in response for the event to thermacare neck shoulder wrist was unknown.Angelini medical assessment: the pi of thermacare neck shoulder wrist mentions that thermal burn could be an adverse event of this medical device, whereas it does not mention intentional device misuse.Dechallenge and rechallenge were unknown.Temporal association adverse events-medical device is plausible.Based on the information provided, the causal relationship between thermacare neck shoulder wrist 12 hour and the reported adverse event thermal burn was considered as possible, for intentional device misuse it was considered not assessable.

• Brand Name: THERMACARE NECK/SHOULDER/WRIST
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): BRIDGES CONSUMER HEALTHCARE; 811 broad street, suite 600; chattanooga TN 37402
• Manufacturer (Section G): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer Contact: rebecca ethridge ; 1231 wyandotte dr; albany, GA 31705 ; 2294463085
• MDR Report Key: 18804320
• MDR Text Key: 336507785
• Report Number: 3007593958-2024-00011
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010396
• UDI-Public: 305733010396
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• 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
• Date Manufacturer Received: 03/12/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female