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

Lot Number EC2324

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

Patient Problems Pain (1994); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.The anticipated date of the next report is (b)(6) 2022.

Event Description

On (b)(6) 2022, bridges consumer healthcare received the following report from angelini 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 2022-028977 is an initial report from germany received on (b)(6) 2022 from a consumer/other non health professional through diamed (de2250).This case report concerns a 48-years-old female patient with back pain), who applied thermacare lower back and hip (batch number ec2324; expiry date sep-2023) for back pain, from (b)(6) 2022 for six hours.Concomitant medications were not reported.On (b)(6) 2022, after thermacare lower back and hip initiation, the patient developed burn blister, pain.A consumer report was received on (b)(6) 2022 regarding thermacare heat wraps for lower back and hip (batch number: ec2324).On (b)(6) 2022, the 48 year-old female consumer used the heat wrap.The indication for use was back pain.After six hours the consumer removed the heat wrap due to pain and discovered burn blisters.Outcome: burn blister : unknown, pain : unknown.The action taken in response to the events was unknown.

Event Description

On (b)(6) 2022, bridges consumer healthcare received the following report from angelini s.P.A.Who received the report on 03-nov-2022.The verbatim of the report is as follows: this serious spontaneous case, manufacturer control number 2022-028977 is an initial report from germany received on 03-nov-2022 from a consumer/other non health professional through diamed (de2250).This case report concerns a 48-years-old female patient with back pain), who applied thermacare lower back and hip (batch number ec2324; expiry date (b)(6) 2023) for back pain, from (b)(6) 2022 for six hours.Concomitant medications were not reported.On (b)(6) 2022, after thermacare lower back and hip initiation, the patient developed burn blister, pain.A consumer report was received on 03-nov-2022 regarding thermacare heat wraps for lower back and hip (batch number: ec2324).On (b)(6) 2022, the 48 year-old female consumer used the heat wrap.The indication for use was back pain.After six hours the consumer removed the heat wrap due to pain and discovered burn blisters.Outcome: burn blister : unknown, pain : 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 (b)(6) 2022.On (b)(6) 2022, bridges consumer healthcare received additional information from angelini s.P.A.The verbatim is as follows: follow up received on (b)(6) 2022 from angelini albany qa department, complaint number (b)(4): batch code#: ec2324 brand code/sku#: f00573301023w product count: 2 count date of manufacture: 16-oct-2020 through 21-oct-2020 expiry date: 2023/ 09 quantity released: 190,692 cartons batch ec2324 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 23-oct-2021, section 8.2: inspection of retain samples.The visual inspection of a retain sample included one carton and the two pouched wraps inside and shows no obvious defects.Form-000094632- retain sample inspection form documented the retain evaluation performed on (b)(6) 2021 for a previous unrelated complaint.An evaluation of the complaint history confirms that this is the first complaint for the sub class adverse event safety request for investigation received at the albany site.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 5.24 was below the upper control limit (ucl) of 8.70 complaints per million produced per trn-000096313, complaint trending guideline, effective (b)(6) 2022.On the basis of this evaluation, a trend does not exist for this batch.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 weremet.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 pal000095139 thermacare lbh/unprinted fc wh-1771-0002-gucci, effective date: 12-oct-2020.There were no wrap attribute or variable defects recorded for the batch.The following complaint intake, triage, and investigation (citi) customizable search and trackwise digital (twd) complaints search were performed: citi scope: date contacted: 11/03/2019 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: (b)(6) 2021 through (b)(6) 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 89 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 relatedprocess 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 (b)(6) 2019 to (b)(6) 2022.There is no further action required.The batch has been reviewed from a manufacturing perspective.There were no known site investigations associated with this batch involving wrap temperature.Root cause investigation required? no capa required? no based on the information provided, the events burn blister and pain 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 does not mention that burn blister and pain could be adverse events of this medical device.Dechallenge and rechallenge were unknown.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 ec2324 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.The complaint was evaluated to identify any potential trend and a trend does not exist for this batch.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.The complaint intake, triage, and investigation (citi) customizable search and trackwise digital (twd) complaints search were performed, a trend does not exist for the subclass adverse event safety request for investigation for lbh products.There is no further action required.The batch has been reviewed from a manufacturing perspective.There were no known site investigations associated with this batch involving wrap temperature.

• Brand Name: THERMACARE LOWER BACK AND HIP 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 ; 4237178579
• MDR Report Key: 15849338
• MDR Text Key: 304175894
• Report Number: 3007593958-2022-00076
• 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
• Report Date: 11/29/2022

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 Expiration Date: 09/01/2023
• Device Lot Number: EC2324
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 11/15/2022
• Supplement Dates FDA Received: 12/01/2022
• 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: 48 YR
• Patient Sex: Female