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

Lot Number EH5504

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

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694); Skin Burning Sensation (4540)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 04-oct-2022, bridges consumer healthcare received a spontaneous report from germany was received from angelini s.P.A.Angelini s.P.A.Received the information on 21-sep-2022.The verbatim is as follows.This serious spontaneous case, manufacturer control number (b)(4) is an initial report from germany received on 21-sep-2022 from a consumer/other non-health professional through diamed (de2186).This case report concerns a female patient (age not reported), who applied thermacare lbh x 2 patches (batch number: eh5504; expiry date: unknown) for unknown indication.Concomitant medications and medical history were not reported.On unspecified date, approximately 2 hours after thermacare lbh x 2 patches initiation, the patient developed burning sensation, burning local, burn blister.After approximately 2 hours of application of the heat belt, the female consumer (age unknown) experienced a sudden most violent burning sensation.After the immediate removal of the belt, she noticed that she had severe burns and severe blisters on her back/hip and buttocks.The consumer had used these belts for years and did not experience any comparable event before, not even any skin irritations.Since the pain had become so persistent that sleeping on her back or on the affected side was no longer possible she decided to consult her doctor the day after her report.Outcome: burning sensation: unknown, burning local: unknown, burn blister : unknown.The action taken with thermacare lbh x 2 patches in response to the events was unknown.

Event Description

On 04-oct-2022, bridges consumer healthcare received a spontaneous report from germany was received from angelini s.P.A.Angelini s.P.A.Received the information on 21-sep-2022.The verbatim is as follows.This serious spontaneous case, manufacturer control number 2022-028650 is an initial report from germany received on 21-sep-2022 from a consumer/other non-health professional through diamed (de2186).This case report concerns a female patient (age not reported), who applied thermacare lbh x 2 patches (batch number: eh5504; expiry date: unknown) for unknown indication.Concomitant medications and medical history were not reported.On unspecified date, approximately 2 hours after thermacare lbh x 2 patches initiation, the patient developed burning sensation, burning local, burn blister.After approximately 2 hours of application of the heat belt, the female consumer (age unknown) experienced a sudden most violent burning sensation.After the immediate removal of the belt, she noticed that she had severe burns and severe blisters on her back/hip and buttocks.The consumer had used these belts for years and did not experience any comparable event before, not even any skin irritations.Since the pain had become so persistent that sleeping on her back or on the affected side was no longer possible she decided to consult her doctor the day after her report.Outcome: burning sensation: unknown, burning local: unknown, burn blister : unknown.The action taken with thermacare lbh x 2 patches in response to the events was unknown.

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.The anticipated date of a follow up report is on 09-nov-2022.On 18-oct-2022, bridges consumer healthcare received additional information from angelini s.P.A.Which recieved the information on 05-oct-2022: follow-up received on 05-oct-2022 from qa department.Complaint number: (b)(4).Batch code#: eh5504 brand code/sku#: f00573301023w product count: 2 count date of manufacture: 19-dec-2020 through 24-dec-2020.Expiry date: 11-2023 quantity released: (b)(4) cartons batch eh5504 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-(b)(4), 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 the two pouched wraps inside, and shows no obvious defects to carton or pouched wraps.Form-000094632, retain sample inspection form documented the retain evaluation performed on 23-nov-2021 for a previous complaint.An evaluation of the complaint history confirms that this is the second complaint for the sub class adverse event safety request or investigation received at the albany site requiring an evaluation for this batch.The complaint was evaluated to identify any potential trend.The calculated complaints per million produced (cpmp) result of 9.22 is above the upper control limit (ucl) of 8.70 complaints per trn--(b)(4) "complaint trending guideline," effective 29-jul-2022.A visual evaluation was performed to identify a trend for the lot and sub-class.A trend was not identified.See the attached eh5504 lbh ae.On the basis of this evaluation, a trend does not exist for this batch.The following complaint intake, triage, and investigation (citi) customizable search and trackwise digital (twd) complaints search were performed: citi scope: date contacted: 09/22/2019 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 09/22/2022 manufacturing site: angelini albany / complaint class: undesirable side effect / complaint sub class: /adverse event safety request for investigation.The citi customizable and twd searches returned a total of (b)(4) complaints for lower back & hip 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.Based on the citi and twd searches, the data did not show an increase over time for 36-months.The chart does show seasonal fluctuations.There is not a trend identified for the subclasses of adverse event safety request for investigation for lower back& hip products, refer to the 36-month attached trend chart lbh -ae 09-22-2019 to 09-22-2022.There is no further action required.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--(b)(4) thermacare agm lower back and hip unprinted (gucci), effective date: 04-dec-2020.There was one wrap attribute defects recorded for the batch on 12-24-2020 for wrap delamination major for a fold-over in the carrier web; this defect would not affect a wrap heating for use.There was no variable defect 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 temperature.Based on the information provided, the events burning sensation, thermal burn and burn blister 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 mention that burning sensation and thermal burn could be adverse events of this medical device, whereas it does not mention burn blister.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 events is considered as possible.

• Brand Name: THERMACARE LOWER BACK AND HIP
• 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 ; 4234142221
• MDR Report Key: 15563773
• MDR Text Key: 301369211
• Report Number: 3007593958-2022-00064
• 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: 10/18/2022

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: 11/01/2023
• Device Lot Number: EH5504
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 10/05/2022
• Supplement Dates FDA Received: 10/21/2022
• 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 Sex: Female