MAUDE Adverse Event Report: ANGELINI THERMACARE HEAT WRAP; HOT OR COLD DISPOSABLE PACK.

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Superficial (First Degree) Burn (2685)

Event Type  Injury  

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.The anticipated date of the next report is (b)(6) 2023.

Event Description

On (b)(6) 2022, bridges consumer healthcare received the report from (b)(6) who received the report on (b)(6) 2022.The report verbatim is as follows: this serious spontaneous case, manufacturer control number (b)(4) is an initial report from germany received on (b)(6) 2022 from a consumer/other non health professional through diamed (de2349).This case report concerns a female patient (age not reported), who applied thermacare heat wraps (batch number and expiry date not reported) for unknown indication on unspecified date.Concomitant medications and medical history were not reported.On unknown date, after thermacare heat wraps initiation, the patient developed burn.The consumer experienced a burn after use of the heat wrap.A "nub" of the patch stuck to her skin and after removal, the nub burst open and a very unpleasant burn in a size of about 2 cm resulted.Outcome: burn : unknown.The action taken in response to the events was unknown.

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.The anticipated date of the next report is 28-jan-2023.On 03-jan-2023, angelini s.P.A.Provided bridges consumer healthcare additional information.Angelini s.P.A.Received the information on 22-dec-2022.This investigation was conducted for an unspecified thermacare product.There was limited device specific information provided.No product type, batch number or return sample was available for evaluation.Without a batch reference number and/or return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Per (b)(4), complaint trending guideline, effective date: 29-jul-2022, the complaint was evaluated to identify any potential trends.A 36-month trend analysis will be conducted for complaints with an unknown lot number since the date of manufacture is not known for unknown lot numbers.The trackwise digital (twd) complaint search was performed for product description listed as thermacare non specific product description.No specific product description (i.E., thermacare lower back and hip, thermacare flexible use xl, thermacare neck shoulder and wrist, etc.) was provided at intake.Complaint investigations were previously handled in the legacy quality tracking system (qts) until 14-mar-2021 and included a specific product description for all complaint records handled in the system.As a result, the scope of search includes trackwise digital (twd) complaint with date contacted beginning on 15-mar-2021 (the implementation date of twd complaints).The twd search includes a product description of "thermacare non specific product description" since there is not a specific product description provided.Twd scope: date contacted: 03-15-2021 through 12-09-2022 manufacturing site: angelini albany / complaint class: undesirable side effect / complaint sub class: adverse event safety request for investigation.The twd search returned a total of 17 complaints for the non specific thermacare products during this time period for the class/subclass.There were no complaints confirmed to have a manufacturing related process root cause for a complaint of adverse event safety request for investigation.Based on this twd search, the data did not show an increase over time.There is not a trend identified for the subclass of adverse event safety request for investigation for thermacare non specific product, refer to the attached trend chart unknown nonspecific ae 03-15-2021 to 12-09-2022.There is no further action required.Based on the information provided, the event 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 wit the use of the device.The pi of thermacare heat wraps mentions that burn could be an adverse event of this medical device.Dechallenge and rechallenge were unknown.Temporal association adverse event-medical device is plausible.Based on the information provided the causal relationship between thermacare heat wraps and event is considered as possible.The investigation was conducted for an unspecified thermacare product.There was limited device specific information provided.No product type, batch number or return sample was available for evaluation.Without a batch reference number and/or return sample, 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 was conducted for complaints with an unknown lot number since the date of manufacture is not known for unknown lot numbers.The twd search returned a total of 17 complaints for the non specific thermacare products during this time period for the class/subclass.There were no complaints confirmed to have a manufacturing related process root cause for a complaint of adverse event safety request for investigation.Based on this twdsearch, the data did not show an increase over time.There is not a trend identified for the subclass of adverse event safety request for investigation for thermacare non specific product.

Event Description

On 22-dec-2022, bridges consumer healthcare received the report from angelini s.P.A.Who received the report on 09-dec-2022.The report verbatim is as follows: this serious spontaneous case, manufacturer control number (b)(4) is an initial report from germany received on 09/dec/2022 from a consumer/other non health professional through diamed (b)(6).This case report concerns a female patient (age not reported), who applied thermacare heat wraps (batch number and expiry date not reported) for unknown indication on unspecified date.Concomitant medications and medical history were not reported.On unknown date, after thermacare heat wraps initiation, the patient developed burn.The consumer experienced a burn after use of the heat wrap.A "nub" of the patch stuck to her skin and after removal, the nub burst open and a very unpleasant burn in a size of about 2 cm resulted.Outcome: burn : unknown.The action taken in response to the events was unknown.

Event Description

On 22-dec-2022, bridges consumer healthcare received the report from (b)(6) who received the report on 09-dec-2022.The report verbatim is as follows: this serious spontaneous case, manufacturer control number (b)(4) is an initial report from germany received on 09/dec/2022 from a consumer/other non health professional through diamed (de2349).This case report concerns a female patient (age not reported), who applied thermacare heat wraps (batch number and expiry date not reported) for unknown indication on unspecified date.Concomitant medications and medical history were not reported.On unknown date, after thermacare heat wraps initiation, the patient developed burn.The consumer experienced a burn after use of the heat wrap.A "nub" of the patch stuck to her skin and after removal, the nub burst open and a very unpleasant burn in a size of about 2 cm resulted.Outcome: burn : unknown.The action taken in response to the events was unknown.

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.The anticipated date of the next report is 28-jan-2023.On 03-jan-2023, angelini s.P.A.Provided bridges consumer healthcare additional information.Angelini s.P.A.Received the information on 22-dec-2022.This investigation was conducted for an unspecified thermacare product.There was limited device specific information provided.No product type, batch number or return sample was available for evaluation.Without a batch reference number and/or return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.Per (b)(4), complaint trending guideline, effective date: 29-jul-2022, the complaint was evaluated to identify any potential trends.A 36-month trend analysis will be conducted for complaints with an unknown lot number since the date of manufacture is not known for unknown lot numbers.The trackwise digital (twd) complaint search was performed for product description listed as thermacare non specific product description.No specific product description (i.E., thermacare lower back and hip, thermacare flexible use xl, thermacare neck shoulder and wrist, etc.) was provided at intake.Complaint investigations were previously handled in the legacy quality tracking system (qts) until 14-mar-2021 and included a specific product description for all complaint records handled in the system.As a result, the scope of search includes trackwise digital (twd) complaint with date contacted beginning on 15-mar-2021 (the implementation date of twd complaints).The twd search includes a product description of "thermacare non specific product description" since there is not a specific product description provided.Twd scope: date contacted: 03-15-2021 through 12-09-2022 manufacturing site: angelini albany / complaint class: undesirable side effect / complaint sub class: adverse event safety request for investigation.The twd search returned a total of 17 complaints for the non specific thermacare products during this time period for the class/subclass.There were no complaints confirmed to have a manufacturing related process root cause for a complaint of adverse event safety request for investigation.Based on this twd search, the data did not show an increase over time.There is not a trend identified for the subclass of adverse event safety request for investigation for thermacare non specific product, refer to the attached trend chart unknown nonspecific ae 03-15-2021 to 12-09-2022.There is no further action required.Based on the information provided, the event 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 wit the use of the device.The pi of thermacare heat wraps mentions that burn could be an adverse event of this medical device.Dechallenge and rechallenge were unknown.Temporal association adverse event-medical device is plausible.Based on the information provided the causal relationship between thermacare heat wraps and event is considered as possible.The investigation was conducted for an unspecified thermacare product.There was limited device specific information provided.No product type, batch number or return sample was available for evaluation.Without a batch reference number and/or return sample, 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 was conducted for complaints with an unknown lot number since the date of manufacture is not known for unknown lot numbers.The twd search returned a total of (b)(4) complaints for the non specific thermacare products during this time period for the class/subclass.There were no complaints confirmed to have a manufacturing related process root cause for a complaint of adverse event safety request for investigation.Based on this twdsearch, the data did not show an increase over time.There is not a trend identified for the subclass of adverse event safety request for investigation for thermacare non specific product.On 04-jan-2023, angelini s.P.A.Provided bridges consumer healthcare additional information.Angelini s.P.A.Was aware of the information on 22-dec-2022.The corrected information is as follows: the incident supplmental chart has been updated.The number of devices on the market have been updated.The bfarm case number (b)(4) was provided.No additional information was provided.

Manufacturer Narrative

On 05-apr-2023 angelini s.P.A.Provided additional information regarding this spontaneous report to bridges consumer healthcare.Angelini s.P.A.Received the information on 03-apr-2023.Follow up received on 03-apr-2023 from qa department.Complaint number: (b)(4): this investigation was conducted for an unspecified thermacare product.There was limited device specific information provided.No product type, batch number or return sample was available for evaluation.Without a batch reference number and/or return sample, a manufacturing evaluation cannot be completed for the wrap involved in this case.No product quality-related trend was identified for the subclass adverse event safety request for investigation.Due to the exclusion of quality defect, the most probable root cause is linked to individual sensitivity and unrelated to the manufacturing process.Care should be taken when using the device, following all safety and use information as provided with the wrap to avoid undesirable side effects.The manufacturing operations employ quality control procedures, including process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.Without batch information available, it is impossible to assign a root cause for this complaint.To identify a most probable root cause, there are pre-identified risk factors that could cause a burn listed in the hazard analysis (rpt-000097160).There are several material and product defect risk factors that are identified and mitigated to reduce the risk of these defects reaching our customers.While the site takes every precaution to identify potential risk, there are multiple risks that are outside the control of the site.These include aspects like age, skin condition, and other medical conditions.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.Data analysis was performed taking the period from 03-15-2021 to 12-09-2022 with complaint sub class: adverse event safety request for investigation.Searches returned a total 17 complaints for the nonspecific thermacare products during this time period for the class/subclass.Over time for 36-months, there is not a trend identified for the subclasses of adverse event safety request for investigation for the nonspecific thermacare products.There is no further action required.The search described in the investigation summary takes into consideration all adverse events.This search was not specific to burns only, therefore it is not intended to be used for determining similar incidents as per mir help text of the commission.Based on the historical data of the complaints received the research was performed for the subclass adverse event safety request for investigation for thermacare non-specific wrap type heatwrap products.The data did not show an increase over time for 36-months.On the basis of this evaluation, a trend does not exist and therefore, the risk assessment included in the technical file is not impacted.Based on the information provided, the event 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 use of the device.The pi of thermacare heat wraps mentions that burn could be an adverse event of this medical device.Dechallenge and rechallenge were unknown.Temporal association adverse event-medical device is plausible.Based on the information provided the causal relationship between thermacare heat wraps and event is considered as possible.This investigation was conducted for an unspecified thermacare product.There was limited device specific information provided.No product type, batch number or return sample was available for evaluation.Without a batch reference number and/or return sample, a manufacturing evaluation cannot be completed for the wrap involved in this case.No product quality-related trend was identified for the subclass adverse event safety request for investigation.Data analysis was performed taking the period from 03-15-2021 to 12-09-2022 with complaint sub class: adverse event safety request for investigation.Searches returned a total 17 complaints for the nonspecific thermacare products during this time period for the class/subclass.Over time for 36-months, there is not a trend identified for the subclasses of adverse event safety request for investigation for the nonspecific thermacare products.Due to the exclusion of quality defect, the most probable root cause is linked to individual sensitivity and unrelated to the manufacturing process.

• Brand Name: THERMACARE HEAT WRAP
• 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: 16044716
• MDR Text Key: 306153839
• Report Number: 3007593958-2022-00096
• Device Sequence Number: 1
• Product Code: IMD
• 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,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/07/2023

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
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 12/23/2022
• Supplement Dates Manufacturer Received: 12/22/2022; 12/22/2022; 04/05/2023
• Supplement Dates FDA Received: 01/03/2023; 01/06/2023; 04/07/2023
• 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