MAUDE Adverse Event Report: ANGELINI THERMACARE LOWER BACK & HIP 8HR S/M 2CT; HOT OR COLD DISPOSABLE PACK.

Model Number	THERMACARE HEATWRAPS - LOWER BACK & HIP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reportable near incident identified.Investigation in progress.
Event or Problem Description
On (b)(6) 2021 , the case was received from (b)(6).The report consisted of a spontaneous report from (b)(6) which was received by (b)(6) on (b)(6) 2021.The verbatim of the report was as follows: this case report concerns an adult female patient (age between 40 and 50), who applied thermacare lower back and hip (batch number x96240, expiry date unknown) for unknown indication.Concomitant medications: unknown.Medical history: unknown.After thermacare lower back and hip initiation, the patient experienced thermal burn.Customer returned the empty pack to the pharmacy and claimed she got burns (blisters).According to customer plaster was worn on bare skin, no cremes have been applied underneath and it has not been worn over night.No contact details for customer are available.The outcome was reported as unknown.The reporter assessed this report as not serious and the company upgraded the case to serious.
Additional Manufacturer Narrative
Reportable near incident identified.Investigation in progress.Follow up information was provided by angelini s.P.A.To bridges consumer health care on 20-may-2021.The following information was provided: follow-up information received from qa department on 07-may-2020 (preliminary report) and on 10-may-2021 (final report) (complaint number:(b)(4)).The information was processed together.Expiry date added:sep-2021, basg no.: 3400635, batch code#: x96240, product count: 4 count, brand code/sku#: f00573301009c, date of manufacture: 28-oct-2018 to 01-nov-2018, quantity released: (b)(4).Batch x96240 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.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 - 41.6 degrees c) per spec 29842, effective date: 24-aug-2018.There were no wrap attribute or variable defects recorded for the batch.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperatures.Per sop-108349, consumer return samples and retain evaluations, effective 30-jul-2020, section 8.2: inspection of retain samples.The visual inspection of a retain sample included one carton and the four pouched wraps inside.There were no obvious defects found on carton or pouched wraps.Form-46455 retain sample inspection form documented the retain evaluation performed on 31-oct-2019 for a non-related complaint.An evaluation of the complaint history confirms that this is the first complaint for the sub class md incident requiring an investigation for this batch.On the basis of this evaluation, a trend does not exist for the batch.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.Capa required:no.Root cause investigation required: no.Based on the information provided, the event burn blister as described in this case is 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.Dechallenge and rechallenge were unknown.Temporal association adverse event-medical device is plausible.Based on the information provided the causal relationship between thermacare lower back and hip and event is considered as possible.
Event or Problem Description
On 28-apr-2021, the case was received from angelini s.P.A.The report consisted of a spontaneous report from austria which was received by angelini s.P.A on 15-apr-2021.The verbatim of the report was as follows: this case report concerns an adult female patient (age between 40 and 50), who applied thermacare lower back and hip (batch number x96240, expiry date unknown) for unknown indication.Concomitant medications: unknown.Medical history: unknown.After thermacare lower back and hip initiation, the patient experienced thermal burn.Customer returned the empty pack to the pharmacy and claimed she got burns (blisters).According to customer plaster was worn on bare skin, no cremes have been applied underneath and it has not been worn over night.No contact details for customer are available.The outcome was reported as unknown.The reporter assessed this report as not serious and the company upgraded the case to serious.

• Brand Name: THERMACARE LOWER BACK & HIP 8HR S/M 2CT
• Common Device Name: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• MDR Report Key: 11793476
• Report Number: 3007593958-2021-00009
• Device Sequence Number: 16984878
• Product Code: IMD
• UDI-Device Identifier: 00305733010020
• UDI-Public: 00305733010020
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/01/2021
• Device Model Number: THERMACARE HEATWRAPS - LOWER BACK & HIP
• Device Lot Number: X96240
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR