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

Lot Number EC2325

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

Patient Problems Partial thickness (Second Degree) Burn (2694); Skin Burning Sensation (4540)

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.The expected date of the follow up report is (b)(6) 2022.

Event Description

On (b)(6) 2022 bridges consumer healthcare received the following report from france via angelini s.P.A which 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 france received on (b)(6) 2022 from a consumer/other non health professional through cooper (mv2022042).Follow-up information received from the consumer on 21-oct-2022 through cooper regarding patient's age, medical history, details on onset of adverse events and their course and treatment.This case report concerns a 48 years old female patient, who applied thermacare heat wraps (batch number ec2325, expiry date: sep-2023) for unknown indication.Concomitant medications were not reported.Medical history included: back pain for a very long time.Approximately 2 months ago, after thermacare heat wraps initiation, the patient experienced burn blister, burning sensation.Due to back problems, the customer purchased a thermacare heat wrap (customer already used thermacare heat wraps in 2016 and 2018, with no incident).She kept the pacth in place the time it heats up (about 1 day).After use, burning sensation.Then she removed the patch, big blisters located at the level of the back.The burn marks do not disappear (confirmed by a dermatologist).The customer left the patch during 6 hours because she felt an unpleasant sensation of burns so she removed the patch.The product was not kept by the patient.Then she had blisters that appeared, she applied a corrective treatment (biafine during 15 days).After this treatment she had brown spots instead of blisters.She bought (caudalie) products (cosmetic cream) for the treatment of burn spots and la roche posay intensive anti-spot serum.Nothing has alleviated the burns.The burn marks do not disappear (confirmed by a dermatologist).She told that she is used to apply synthol and thermacare heating patches for many years due to her back problems.Outcome: burn blister : not recovered/not resolved, burning sensation : unknown.The action taken in response to the events for thermacare heat wraps was device discontinued.

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.The expected date of the follow up report is 07-dec-2022.On (b)(6) 2022, (b)(6) healthcare received additional information from angelini s.P.A.The verbatim is as follows.Follow up received on 18-nov-2022 from angelini albany qa department (cn-088562).Investigational summary: batch code#: ec2325 brand code/sku#: f00573301025w product count: 2 count date of manufacture: 02-oct-2020 to 03-oct-2020 expiry date: 2023-09-30 quantity released: 100,212 cartons batch ec2325 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 sample and retain evaluation was performed.The visual inspection of a retain sample included one carton and two pouched wraps and shows no obvious defects to carton or pouched wraps.Form-000094632, retain sample inspection form documented the retain evaluation performed on (b)(6) 2022 for an 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 requiring an investigation by the site.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 10.0 was above the upper control limit (ucl) of 8.70 complaints per trn-000096313 "complaint trending guideline," effective 29-jul-2022.Per trn-000096313, avisual evaluation was performed to identify a potential trend for the lot and subclass.A trend was not identified.Refer to attachment ec2325 lbh adverse event.On this basis, 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.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 fcwh-1771-0002 (gucci), effective date: 13-aug-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: 10/18/2019 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 10/18/2022 manufacturing site: angelini albany / complaint class: undesirable side effect/complaint sub class: adverse event safety requested for investigation.The citi customizable and twd searches returned a total of 87 complaints for lbh products duringthis period for the class/subclass.None of the complaints were confirmed to have a manufacturing 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.Refer to the 36-month trending chart attachment lbh-ae 10-18-2019 to 10-18-2022.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 seasonalfluctuations.There is not a trend identified for the subclasses of adverse event safety request for investigation for lower back hip (lbh) 8hr 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.Based on the information provided, the events burn blister and burning sensation 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 could be an adverse event of this medical device, whereas it mentions burning sensation.Temporal association adverse events-medical device isplausible.Based on the information provided the causal relationship between thermacare lower back and hip and incident is considered as possible.Batch ec2325 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.The visual inspection of a retain sample included one carton and two pouched wraps and shows no obvious defects to carton or pouched wraps.An evaluation of the complaint history confirms that this is the first complaint for the sub-class adverse event safety request for investigation requiring an investigation by the site.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 attribute or variable defects recorded for the batch.Complaint intake, triage, and investigation (citi) customizable search and trackwise digital (twd) complaints search were performed.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.The batch has been reviewed from a manufacturing perspective.There were no known site investigations associated with this batch involving wrap temperature.

Event Description

On (b)(6) 2022 bridges consumer healthcare received the following report from france via angelini s.P.A which received the report on 18-oct-2022.The report verbatim is as follows: this serious spontaneous case, manufacturer control number (b)(4) is an initial report from france received on 18-oct-2022 from a consumer/other non health professional through cooper (b)(4).Follow-up information received from the consumer on (b)(6) 2022 through cooper regarding patient's age, medical history, details on onset of adverse events and their course and treatment.This case report concerns a 48 years old female patient, who applied thermacare heat wraps (batch number ec2325, expiry date: sep-2023) for unknown indication.Concomitant medications were not reported.Medical history included: back pain for a very long time.Approximately 2 months ago, after thermacare heat wraps initiation, the patient experienced burn blister, burning sensation.Due to back problems, the customer purchased a thermacare heat wrap (customer already used thermacare heat wraps in 2016 and 2018, with no incident).She kept the pacth in place the time it heats up (about 1 day).After use, burning sensation.Then she removed the patch, big blisters located at the level of the back.The burn marks do not disappear (confirmed by a dermatologist).The customer left the patch during 6 hours because she felt an unpleasant sensation of burns so she removed the patch.The product was not kept by the patient.Then she had blisters that appeared, she applied a corrective treatment (biafine during 15 days).After this treatment she had brown spots instead of blisters.She bought (caudalie) products (cosmetic cream) for the treatment of burn spots and la roche posay intensive anti-spot serum.Nothing has alleviated the burns.The burn marks do not disappear (confirmed by a dermatologist).She told that she is used to apply synthol and thermacare heating patches for many years due to her back problems.Outcome: burn blister : not recovered/not resolved, burning sensation : unknown.The action taken in response to the events for thermacare heat wraps was device discontinued.

• Brand Name: THERMACARE HEAT WRAPS
• 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: 15708536
• MDR Text Key: 302778503
• Report Number: 3007593958-2022-00073
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/02/2022

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: EC2325
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/01/2022
• Supplement Dates Manufacturer Received: 11/18/2022
• Supplement Dates FDA Received: 12/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female