MAUDE Adverse Event Report: ANGELINI THERMACARE NECK/SHOULDER/WRIST 8HR; HOT OR COLD DISPOSABLE PACK.

Device Problems Insufficient Information (3190); Excessive Heating (4030)

Patient Problems Local Reaction (2035); Full thickness (Third Degree) Burn (2696)

Event Type  malfunction  

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.The expected date of the next report is 02-may-2023.

Event Description

Angelini s.P.A.Provided this spontaneous report from germany to bridges consumer healthcare on 24-mar-2023.Angelini s.P.A.Received the report on 13-mar-2023.The report verbatim is as follows: this serious spontaneous case, manufacturer control number (b)(4) is an initial report from germany received on 13-mar-2023 from a pharmacist through diamed (de2636).This case report concerns a female patient, who applied thermacare neck shoulder patches (batch number and expiry date unknown) used for unknown indication.Concomitant medications and medical history were not reported.On an unknown date, after thermacare neck shoulder initiation, the patient experienced burns third degree, application site discomfort, device overheating.The pharmacist reported an incident with thermacare heat wraps (neck and shoulder patches), which resulted in a 3rd degree burn.On 14-mar-2023, additional information was received from the pharmacist via telephone.A female patient (born 1941) had used the heat wrap for an unknown indication on her neck and shoulder area.She had used the product before several times without any issues.The patient applied the heat wrap on an unknown date.About three hours after the administration, the patient felt a feeling of discomfort and immense heat in the area of the applied patch.The patient removed the heat wrap.She further noticed that the patch was exceptionally hot.It remained unclear whether the patient had used the heat wrap on the bare skin or wore a t-shirt beneath it.No information regarding the batch number was available as the patient had already thrown away the package.The patient went to the doctor and received treatment for the burns.Outcome: burns third degree unknown, application site discomfort : unknown, device overheating : unknown.The action taken in response to the events for thermacare neck shoulder patches was unknown.

Manufacturer Narrative

On 18-may-2023, bridges consumer healthcare received additional information from (b)(6) who received the information on 05-may-2023.The report verbatim is as follows: follow-up received on 05-may-2023 from qa department.Complaint number (b)(4).Considering the current information available for this complaint it is not possible to determine a root cause.This complaint is not justified, and no batch number was available.Without a batch reference number a manufacturing evaluation cannot be completed for the wrap involved in this case.Without a reported defect, it is not possible to determine the most probable root cause.However, there are pre-identified risk factors that could cause a burn listed in the hazard analysis (b)(4).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.Our manufacturing operations employ quality control procedures which include in process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.This complaint was subject to review in order to identify any potential trends.A 36-month trend analysis was conducted for complaints with an unknown batch number since the date of manufacture is unknown.The search returned a total of 11 complaints for the neck, shoulder wrist 12 hour products during this time period for the class/subclass.None were confirmed to have a manufacturing related process root cause for a complaint of adverse event safety request for investigation (including burns).The search did not show an increase over time for 36-months.There is not a trend identified for the subclasses of adverse event safety request for investigation for neck, shoulder, wrist (nsw) products.Based on the information provided, the event of burns third degree, application site discomfort and device overheating 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 use of the device.The pi of thermacare neck shoulder patches mentions that burns third degree and application site discomfort could be adverse events of this medical device, whereas it does not mention device overheating.Temporal association adverse events-medical device is plausible.Based on the information provided the causal relationship between thermacare neck shoulder patches and adverse events is considered as possible, whereas for device overheating it is considered not assessable.This investigation was conducted for an unknown batch number of neck shoulder wrist 12-hour product 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.The search did not show an increase over time for 36-months.Chart shows seasonal fluctuations.There is not a trend identified.There is no further action required.The root cause cannot be identified.Pt: burns third degree, application site discomfort and device temperature issue meddra codes were used instead of the imdrf codes at this time to be able to fully identify previous reports of similar incidents.

• Brand Name: THERMACARE NECK/SHOULDER/WRIST 8HR
• Type of Device: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer (Section G): BRIDGES CONSUMER HEALTHCARE; 811 broad street, suite 600; chattanooga TN 37402
• Manufacturer Contact: scott hughes ; 811 broad street, suite 600; chattanooga, TN 37402 ; 4234142221
• MDR Report Key: 16637932
• MDR Text Key: 312247202
• Report Number: 3007593958-2023-00016
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010396
• UDI-Public: 305733010396
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2023
• 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