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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGELINI THERMACARE LOWER BACK AND HIP 8HR L/XL; HOT OR COLD DISPOSABLE PACK.
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ANGELINI THERMACARE LOWER BACK AND HIP 8HR L/XL; HOT OR COLD DISPOSABLE PACK. Back to Search Results
Lot Number AR5203
Device Problem Insufficient Information (3190)
Patient Problem Erythema (1840)
Event Date 12/18/2021
Event Type  malfunction  
Event Description
This spontaneous report from the united states was received from a consumer via telephone on (b)(6) 2022.The consumer is a non-smoking 63-year-old female with a past medical history including back pain and an allergy to thimerosal.Concomitant supplement use included a multivitamin.On approximately (b)(6) 2021, the consumer applied the thermacare lower back and hip (large/x-large) wrap to her back, over a silky shirt.She was using the product for back pain, as recommended by her physical therapist.She reported that the product became too hot, therefore, she removed the product after about 45 minutes.After removal of the product, the device site had become red, although this redness resolved that same day, on (b)(6) 2021.She confirmed that there were no blisters or sores at the application site.No additional information was received.
 
Manufacturer Narrative
The root cause cannot be identified.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "after removal of the product, the device site had become red" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device.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.
 
Manufacturer Narrative
The root cause cannot be identified.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "after removal of the product, the device site had become red" is inconclusive since review of records does not provide evidence to support defective product.The product effect may vary with each individual.Care should be taken when using the device.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.On (b)(6) 2022, additional manufacturer narrative from angelini s.P.A.The updated aware date is (b)(6) 2022.The root cause cannot be identified.After a review of the batch thermal records, thermal results all met product release criteria.Consumer reports "after removal of the product, the device site had become red" is inconclusive since review of records does not provide evidence to support defective product.Evaluation of the returned sample did not provide any additional evidence as to why the consumer stated the "device site had become red".There were no obvious defects found as a result of the evaluation.The product effect may vary with each individual.Care should be taken when using the device.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.This is an adverse event for a report of "device site had become red"; a risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction and evaluation of the returned sample did not identify any obvious defects to the product.
 
Event Description
This spontaneous report from the united states was received from a consumer via telephone on (b)(6) 2022.The consumer is a non-smoking 63-year-old female with a past medical history including back pain and an allergy to thimerosal.Concomitant supplement use included a multivitamin.On approximately (b)(6) 2021, the consumer applied the thermacare lower back and hip (large/x-large) wrap to her back, over a silky shirt.She was using the product for back pain, as recommended by her physical therapist.She reported that the product became too hot, therefore, she removed the product after about 45 minutes.After removal of the product, the device site had become red, although this redness resolved that same day, on (b)(6) 2021.She confirmed that there were no blisters or sores at the application site.No additional information was received.
 
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Brand Name
THERMACARE LOWER BACK AND HIP 8HR L/XL
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 Key15934384
MDR Text Key307924893
Report Number3007593958-2022-00081
Device Sequence Number1
Product Code IMD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/01/2022
Device Lot NumberAR5203
Initial Date Manufacturer Received 11/15/2022
Initial Date FDA Received12/07/2022
Supplement Dates Manufacturer Received12/08/2022
Supplement Dates FDA Received12/27/2022
Date Device Manufactured04/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MULTIVITAMIN.; MULTIVITAMIN.
Patient Outcome(s) Required Intervention;
Patient Age63 YR
Patient SexFemale
Patient Weight66 KG
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