MAUDE Adverse Event Report: ANGELINI THERMACARE LOWER BACK AND HIP; HOT OR COLD DISPOSABLE PACK.

Lot Number GA0278

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problem Superficial (First Degree) Burn (2685)

Event Type  Injury  

Manufacturer Narrative

Follow up received on 05-dec-2022 from qa albany department (b)(4).Batch code#: (b)(4) product count: 4 count brand code/sku#: (b)(4) date of manufacture: 01-feb-2022 through 02-feb-2022 expiry date: 2025-01-31 quantity released: 31,944 cartons batch (b)(4) is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Per trn-000096410, consumer return samples and retain evaluations, effective (b)(6) 2021, section 8.2: inspection of retain samples.The visual evaluation of a retain sample included one carton and four pouched wraps and shows no obvious defects.Form-000094632 retain sample inspection form was used document the retain evaluation on (b)(6) 2022.The following complaint intake, triage, and investigation (citi) customizable search and trackwise digital (twd) complaints search were performed: citi scope: date contacted: 11/17/2019 through 03/14/2021 manufacturing site: pfizer albany /complaint class: external cause investigation / complaint sub class: adverse event safety requested for investigation.Twd scope: date contacted: 03/15/2021 through 11/17/2022 manufacturing site: angelini albany / complaint class: undesirable side effect/ complaint sub class: adverse event safety requested for investigation.The citi and twd searches returned a total of 90 complaints for the lower back hip 8-hour (lbh) 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.The citi and twd searches performed for the subclass adverse event safety request for investigation for lower back hip 8hr products did not show an increase over time for 36-months.Chart shows seasonal fluctuations.Based on the citi and twd searches, a trend does not exist for the subclass adverse event safety request for investigation for lbh products.Refer to the 36-month attached trend chart lbh adverse event 11-17-2019 to 11-17-2022.There is no further action required.An evaluation of the complaint history confirms that this is the first complaint for the subclass adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 31.3 was above the upper control limit (ucl) of 8.70 complaints per trn-000096313 "complaint trending guideline," effective (b)(6) 2022.Per trn-000096313, a visual evaluation was performed to identify a potential trend.A trend was not identified.See attached (b)(4) adverse event.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.Thermal data for the batch shows all wraps met the required wrap batch average temperatures (37.6 degrees c to 41.6 degrees c) per pal-000095139, thermacare lower back and hip, unprinted, effective date: (b)(6) 2021.There were no wrap variable defects recorded for the batch.There were no wrap attribute defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch that would contribute to an adverse event.Based on the information provided, the events burn and device use error as described in this case are 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 lower back and hip mentions that burn could be an adverse event of this medical device, whereas it does not mention device use error.Temporal association adverse events-medical device is plausible.Based on the information provided the causal relationship between thermacare lower back and hip and incident is considered as possible.Batch (b)(4) is the only batch within the scope of this investigation.The device history record (dhr), reserve samples, and trending were evaluated.No quality issues were identified.Complaint intake, triage, and investigation (citi) customizable search and trackwise digital (twd) complaints search were performed.The citi and twd searches returned a total of 90 complaints for the lower back hip 8-hour (lbh) 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.Based on the citi and twd searches, a trend does not exist for the subclass adverse event safety request for investigation for lbh products.There is no further action required.An evaluation of the complaint history confirms that this is the first complaint for the subclass adverse event safety request for investigation received at the albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.A trend was not identified.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap variable defects recorded for the batch.There were no wrap attribute defects recorded for the batch.

Event Description

On (b)(6) 2022, bridges consumer healthcare received a spontaneous report from spain.The report was provided by angelni s.P.A.Who received the report on (b)(6) 2022.The verbatim of the report is as follows: this serious spontaneous case, manufacturer control number 2022-029096 is an initial report from spain received on 18/nov/2022 from a consumer/other non-health professional through customer service (ang-es22-073-ps).This case report concerns a 47-years-old male patient, who applied thermacare lower back and hip ((batch n: g a02780202202501121/ exp date: 01/01/2025) for neck contracture.Concomitant medications and medical history were not reported.On unspecified date, after thermacare lower back and hip initiation, the patient experienced burn, device use error.Patient was advised by pharmacist to use thermacare patches indicated for lumbar zone and hip in his neck for a contracture.After 8 hours of application the patch was still very hot and the patient experienced a burn, which is being treated with cicaplast baume b5.He is waiting for a visit with his dermatologist.Outcome: burn: unknown, device use error: unknown.The action taken in response to the event was unknown.

Manufacturer Narrative

On 05-apr-2023 angelini s.P.A.Provided additional information to bridges consumer healthcare.Angelini s.P.A.Received the additional information on 03-apr-2023.Follow up received on 03/apr/2023 from qa albany department (cn-089075): batch code: ga0278.Product count: 4 count.Brand code/sku: f00573301034w.Date of manufacture: 01-feb-2022 through 02-feb-2022.Expiry date: 2025-01-31.Quantity released: (b)(4) cartons.Consumer reports she received a burn on her back.After a review of the batch records, thermal results all met product release criteria.The cause of the consumer receiving a burn is inconclusive since review of records does not provide evidence to support defective product.Due to the exclusion of quality defect, the most probable root cause is linked to device use error and off-label use.The product effect may vary with each individual.Care should be taken to use the device as it was designed, following all safety and use information as provided with the wrap to avoid the risks of 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.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by 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 some risks that are unrelated to the manufacturing process.These include aspects like age, skin condition, other medical conditions, device use error and off-label use.The warning labels on our product report the appropriate instructions for use to our customers to avoid burns.Data analysis was performed taking the period from 11-17-2019 to 11-17-2022 with complaint sub class: adverse event safety request for investigation.Searches returned a total of 90 complaints for the lower back hip 8-hour (lbh) products during this time period for the class/subclass.For a complaint of adverse event safety request for investigation.Over time for 36-months, there is not a trend identified for the subclasses of adverse event safety request for investigation for lower back hip 8-hour (lbh) 8hr products.There is no further action required.This search includes all adverse events, not only those for burns, therefore it is not intended to be used for determining similar incidents as per mir help text of the commission.Risk analysis summary: the risk analysis was performed following wi-000087724, risk analysis/criticality, effective 31-jan-2022, version 3.0.The severity associated with this complaint is moderate.The occurrence is likely with a parts per million (ppm) result of 3.19 ppm (first confirmed complaint for the sub class adverse event safety requested for investigation) for product code f00573301034w (total quantity produced 313,104 baches within 12 months) received at the albany site requiring an evaluation for this batch.The detectability is high as all thermacare product labeling contains a warning regarding use.Per spe-000095309; thermacare core data sheet, version 2.0, section 3.2 directions effective date 16-nov-2020 " place on pain area with darker heat cells toward skin" is visible to patient/user.The overall risk is minor.Impact analysis no impact is identified.Based on the information provided, the events burn, device use error and off label use as described in this case are 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 lower back and hip mentions that burn could be an adverse event of this medical device, whereas it does not mention device use error and off label use.Temporal association adverse events-medical device is plausible.Based on the information provided the causal relationship between thermacare lower back and hip and incident is considered as possible.Batch ga0278 is the only batch within the scope of this investigation.After a review of the batch records, thermal results all met product release criteria.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Data analysis was performed taking the period from 11-17-2019 to 11-17-2022 with complaint sub class: adverse event safety request for investigation.Searches returned a total of 90 complaints for the lower back hip 8-hour (lbh) products.There is not a trend identified for the subclasses of adverse event safety request for investigation for lower back hip 8-hour (lbh) 8hr products.Due to the exclusion of quality defect, the most probable root cause is linked to device use error and off-label use.

• Brand Name: THERMACARE LOWER BACK AND HIP
• 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 ; 4237178579
• MDR Report Key: 15997531
• MDR Text Key: 305681717
• Report Number: 3007593958-2022-00091
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

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
• Device Lot Number: GA0278
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 04/05/2023
• Supplement Dates FDA Received: 04/07/2023
• Date Device Manufactured: 02/01/2022
• 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 Age: 47 YR
• Patient Sex: Male