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

Lot Number G0284

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 12/06/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, bridge consumer healthcare received a thermacare report via email from angelini s.P.A.Who received the report on (b)(6) 2022.The verbatim of the report is as follows: this serious spontaneous case, manufacturer control number 2022-029286 is an initial report from (b)(6) received on (b)(6) 2022 from a pharmacist through diamed (de2342).Additional information was received on 12-dec-2022 and managed with the initial.This case report concerns a female patient (between 40 to 50 years), who applied thermacare lower back and hip (batch number g0284; expiry date unknown) on her back for unapproved indication, from (b)(6) 2022 to (b)(6) 2022.Concomitant medications and medical history were not reported.On (b)(6) 2022, after thermacare lower back and hip initiation, the patient developed burn blister and intentional device misuse.She used therma care heat wraps on two consecutive days, each for approximately 8 hours.On (b)(6) 2022, she had no complaints after use of the heat wrap.On (b)(6) 2022, she experienced burn blisters on her back [brandblasen am rücken] after use of the heat wrap.There was no medical indication for use; the consumer used the heat wraps to keep herself warm as she worked outside (at the christmas market).In the morning of (b)(6) 2022, she presented herself at a pharmacy and bought a burn ointment for treatment of the burn blisters.Outcome: burn blister : unknown intentional device misuse: unkown.The action taken in response to the event was unknown.

Manufacturer Narrative

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

Event Description

On 20-dec-2022, bridge consumer healthcare received a thermacare report via email from (b)(6) who received the report on 07-dec-2022.The verbatim of the report is as follows: this serious spontaneous case, manufacturer control number 2022-029286 is an initial report from germany received on 07/dec/2022 from a pharmacist through diamed (de2342).Additional information was received on 12-dec-2022 and managed with the initial.This case report concerns a female patient (between 40 to 50 years), who applied thermacare lower back and hip (batch number g0284; expiry date unknown) on her back for unapproved indication, from (b)(6) 2022.Concomitant medications and medical history were not reported.On (b)(6) 2022, after thermacare lower back and hip initiation, the patient developed burn blister and intentional device misuse.She used therma care heat wraps on two consecutive days, each for approximately 8 hours.On (b)(6) 2022, she had no complaints after use of the heat wrap.On (b)(6) 2022, she experienced burn blisters on her back [brandblasen am rücken] after use of the heat wrap.There was no medical indication for use; the consumer used the heat wraps to keep herself warm as she worked outside (at the christmas market).In the morning of (b)(6) 2022, she presented herself at a pharmacy and bought a burn ointment for treatment of the burn blisters.Outcome: burn blister : unknown intentional device misuse: unkown.The action taken in response to the event was unknown.

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.The anticipated date of the next report is 26-jan-2023.On 02-jan-2023, bridges consumer healthcare received additional information from angelini s.P.A.Who received the information on 20-dec-2022.The report verbatim is as follows: batch #: ga0284 brand code/sku#: f00573301064w product count: 6 count date of manufacture: 03-feb-2022 to 07-feb-2022 expiry date: 2025-01-31 quantity released: 75,834 cartons batch ga0284 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 samples.The visual evaluation of a retain sample included five (5) cartons, thirty (30) pouches and 30 wraps.All 30 wraps have sealed cell packs, no damage, or leaking cells.One wrap from run day 5 (07-feb-2022) contained minor stray chemistry.Form-000094632 retain sample inspection form was used to document the retain evaluation on 26-aug-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.Per trn-000096313, complaint trending guidelines, effective 29-jul-2022.The calculated cpmp result of 13.18 was above the upper control limit (ucl) of 8.70.A visual evaluation was performed to identify any potential trend for the batch and subclass.A trend was not identified.Refer to attachment ga0284 lbh ae history.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: 12/07/2019 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 12/07/2022 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 95 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, a trend does not exist for the subclass adverse event safety request for investigation for lower back hip products.Refer to the 36-month trending chart attachment lbh ae 12-07-2019 to 12-07-2022.No further action is 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.There were no wrap attribute or variable defects recorded for the batch.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, effective date: 07-may-2021.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.A total of 3,648 pti (pouch leak) tests were performed with two failures.Pouch leak maximum acceptance limit for a sample size of 3640 pti tests is 65 failures per pouch leak test sampling plan extension pln-000097247, effective date: 06-mar-2017.There were no open pouch defects recorded.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 of burn blister and intentional device misuse 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.Batch ga0284 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.Inspection of retain samples, since consumer return samples.The visual evaluation of a retain sample included five (5) cartons, thirty (30) pouches and 30 wraps.All 30 wraps have sealed cell packs, no damage, or leaking cells.One wrap from run day 5 (07-feb-2022) contained minor stray chemistry.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.A visual evaluation was performed to identify any potential trend for the batch and subclass.A trend was not identified.On the basis of this evaluation, 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.There were no wrap attribute or variable defects recorded for the batch.Thermal data for the batch shows all wraps met the required wrap batch average temperatures.Review of the packaging attributes (pouch, carton, and shipper container) quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria was met.There were no open pouch defects recorded.This batch has been reviewed from a manufacturing perspective.There are no known site investigations associated with this batch involving wrap temperature.

• 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: 16035449
• MDR Text Key: 306012851
• Report Number: 3007593958-2022-00094
• 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,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: G0284
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2022
• 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 Age: 40 YR
• Patient Sex: Female