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

Lot Number GA0204

Device Problem Excessive Heating (4030)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2023 angelini s.P.A.Received the report from germany.Angelini s.P.A.Provided the report to bridges consumer healthcare on (b)(6) 2023.The verbatim of the report is as follows: this serious spontaneous case, manufacturer control number (b)(4) is an initial report from germany received on (b)(6) 2023 from a consumer/other non-health professional through diamed (de2572).Additional information about the treatment duration was received on (b)(6)2023.The information was processed and merged together.This case report concerns a 74-years-old female patient, who applied thermacare heat wraps back (batch number ga0204, expiry date unknown) used for unknown indication.Concomitant medications and medical history were not reported.After thermacare heat wraps back initiation, the patient experienced burn blisters and mild burns [brandblasen (leichte verbrennungen)] coded as burn blister, burn.Furthermore, the heat wrap was described as too hot (product quality complaint).The patient stated that she had used the heat wrap for 1.5 hours and after removing the wrap she detected the burn blisters.Outcome: burn blister: unknown, burn: unknown, product quality complaint : unknown.The action taken in response to the events for thermacare heat wraps back was unknown.

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.The date of the next anticipated report is 14-apr-2023.On 09-mar-2023, angelini s.P.A.Received additional information.On 21-mar-2023, angelini s.P.A.Provided the information to bridges consumers healthcare.The report verbatim follows: follow-up received on 09/mar/2023 from qa department.Complaint number: (b)(4).Batch #: ga0204.Brand code/sku#: h000024564.Product count: bulk count.Date of manufacture: 19-aug-2021 through 26-aug-2021.Expiry date: 31-jul-2024.Quantity released: (b)(4) cartons.Parent batch ga0204 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.Batch ga0204 was manufactured as a bulk batch (h000024564, 806,400 quantity released), the batch was sent to cit pharma contract packaging for packaging into sub-lots.The information in this investigation was taken from the parent batch ga0204.This device history record (dhr), reserve sample, 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 evaluation of retain samples included 48 pouches and the wraps inside the pouches.The evaluation shows no obvious defects to pouches or wraps.Form-000094632 retain sample inspection form was used to document the retain evaluation on 18-aug-2022 for an unrelated complaint.Per trn-000096313, complaint trending guideline, effective 29-jul-2022, the complaint was evaluated to identify a potential trend for the lot and subclass.The upper control limit (ucl) for the subclass adverse event safety request for investigation is 8.70.This is the second complaint for parent batch ga0204 resulting in a calculated cpmp of 2.48 which is below the (ucl) of 8.70.On the basis of this evaluation, a trend does not exist for this lot.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attribute and variable quality checks associated with this batch indicate 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-000095032, thermacare flex use large muscle (salt 2.0 ), effective date: 10-may-2021.There was one wrap attribute defect recorded on 24-aug-2021 for undosed (dead cell).The brine pump a-2 was replaced, no product was scrapped.There was no wrap variable defects recorded for the batch.The following complaint intake, triage, and investigation (citi) customizable search and trackwise digital (twd) complaints searches were performed: citi scope: date contacted: 02/24/2020 through 03/14/2021 manufacturing site: pfizer albany /complaint class: external cause investigation / complaint sub class: adverse event safety request for investigation.Twd complaints scope: date contacted: 03/15/2021 through 02/24/2023 manufacturing site: angelini albany / complaint class: undesirable side effect /complaint sub class: /adverse event safety request for investigation.The citi customizable and twd search returned a total of 17 complaints for flexible use xl products during this 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.There was a spike in july 2020.Five complaints were for burns from the same lot number aa2381.The batch thermal records were reviewed.The thermal results all met product release criteria.The cause of the consumer indicating they received burns were inconclusive since the review of records did not provide evidence to support a product defect.Based on the customizable citi and twd search, a trend does not exist for the subclass adverse event safety request for investigation for flex xl 8hr products.Refer to the 36-month trending chart attachment flex use xl ae 02-24-2020 to 02-24-2023.No further action is required.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperature.Angelini medical assessment: the pi of thermacare heat wraps back mentions that burn blister and burn could be adverse events of this medical device, whereas it does not mention product quality complaint.Dechallenge and rechallenge were not applicable.Temporal association adverse events-medical device is plausible.Based on the information provided, the causal relationship between thermacare heat wraps back and the reported adverse events was considered as possible, whereas for product quality complaint it was considered not assessable.The overall assessment for this case is serious/unlabeled/possible parent batch ga0204 is the only batch within the scope of this investigation.The information in this investigation was taken from the parent batch ga0204.This device history record (dhr), reserve sample, and trending were evaluated.No quality issues were identified.The visual evaluation of retain samples included 48 pouches and the wraps inside the pouches.The evaluation shows no obvious defects to pouches or wraps.The complaint was evaluated to identify a potential trend for the lot and subclass.On the basis of this evaluation, a trend does not exist for this lot.Review of the batch device history record for this batch concludes all release requirements were met.There was no wrap variable defects recorded for the batch.

Event Description

On 24-feb-2023 angelini s.P.A.Received the report from germany.Angelini s.P.A.Provided the report to bridges consumer healthcare on 09-mar-2023.The verbatim of the report is as follows: this serious spontaneous case, manufacturer control number 2023-030231 is an initial report from germany received on 24-feb-2023 from a consumer/other non-health professional through diamed (de2572).Additional information about the treatment duration was received on 24-feb-2023.The information was processed and merged together.This case report concerns a 74-years-old female patient, who applied thermacare heat wraps back (batch number ga0204, expiry date unknown) used for unknown indication.Concomitant medications and medical history were not reported.After thermacare heat wraps back initiation, the patient experienced burn blisters and mild burns [brandblasen (leichte verbrennungen)] coded as burn blister, burn.Furthermore, the heat wrap was described as too hot (product quality complaint).The patient stated that she had used the heat wrap for 1.5 hours and after removing the wrap she detected the burn blisters.Outcome: burn blister: unknown, burn: unknown, product quality complaint : unknown.The action taken in response to the events for thermacare heat wraps back was unknown.

• Brand Name: THERMACARE LOWER BACK AND HIP HEAT WRAP
• Type of Device: HOT OR COLD DISPOSIBLE PACKS.
• 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: 16531930
• MDR Text Key: 311219124
• Report Number: 3007593958-2023-00013
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733010396
• UDI-Public: 305733010396
• 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: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: GA0204
• Date Manufacturer Received: 03/09/2023
• 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 Age: 74 YR
• Patient Sex: Female