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

Lot Number GA0178

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

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

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2022, a spontaneous report was received by bridges consumer healthcare 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 (b)(4) is an initial report from germany received on (b)(6) 2022 from a pharmacist through diamed (de2136).Follow-up information was received via phone call with the reporting pharmacy on 26-aug-2022 through diamed regarding the patients age, sex, and symptoms.The information was merged and processed together.This case report concerns an adult female patient (early 20s), who topically applied thermacare heat wraps lower back and hip (batch number ga0178, expiry date unknown) for unknown indication.Concomitant medication were not reported.The patient had previous experience with thermacare and previous use of thermacare was successful.On unknown date, after thermacare heat wraps (lower back and hip) initiation, the patient developed burn blister.The heat wrap got so hot that the consumer suffered a burn blister approximately 1 to 1.5 cm in size underneath the heat wrap.The consumer was not wearing tight clothing which could explain the burn blister.

Manufacturer Narrative

Reportable near incident identified.Investigation in progress.The anticipated date of the next follow up report is 12-oct-2022.On 20-oct-2022, bridges consumer healthcare received additional information from angelini s.P.A.Who received the information on 07-oct-2022.The verbatim of the information is as follows: batch #: ga0178.Brand code/sku#: f00573301023w.Product count: 2 count.Date of manufacture: 26-oct-2021 to 30-oct-2021.Expiry date: 2024-09.Quantity released: (b)(4) cartons.Batch ga0178 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 inspection of a retain sample included one carton and the two pouched wraps inside and shows no obvious defects.Form -0000946632 retain sample inspection form documented the retain evaluation performed on 15-mar-2022 for an unrelated complaint.An evaluation of the complaint history confirms that this is the first complaint for the sub-class wrap/patch/pad wrap/patch/pad too hot received at the albany site requiring an evaluation of this batch.Per trn-000096313, complaint trending guideline, effective 29-jul-2022, the complaint was evaluated to identify a potential trend for the lot 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.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, effective date: 07-may-2021.There were no wrap attribute defects or variable defects recorded for the batch that would affect wrap temperature or wrap heating up for use.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 4320 pti (pouch leak) tests were performed with four (4) failures.Pouch leak maximum acceptance limit for a sample size of 4300 pti tests is 77 failures per pouch leak test sampling plan extension pln-000097247, effective date: 06-mar-2017.There were no pack attribute defects recorded for open pouches.The following complaint intake, triage, and investigation (citi) customizable search and trackwise digital (twd) complaints search were performed: citi scope: date contacted: 08/23/2019 through 03/14/2021 manufacturing site: pfizer albany /complaint class: product use attributes / complaint sub class: too hot.Twd scope: date contacted 03/15/2021 through 08/23/2022 manufacturing site: angelini albany/ complaint class: product and usage defects/ complaint sub class: wrap/patch/pad too hot.The citi customizable and twd search returned a total of 21 complaints for lower back/hip (lbh)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 wrap patch pad too hot.Based on the customizable citi and twd searches, a trend does not exist for the subclass wrap patch pad too hot for lbh 8hr products.Refer to the 36-month trending chart attachment wrap patch pad too hot lbh 08-23-2019 to 08-23-2022.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 pouch sealing or wrap temperature.Root cause investigation required: no.Capa 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 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.Batch ga0178 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.An evaluation of the complaint history confirms that this is the first complaint for the sub-class wrap/patch/pad wrap/patch/pad too hot received at the albany site requiring an evaluation of this batch.The complaint was evaluated to identify a potential trend for the lot and subclass.A trend was not identified.On the basis of this evaluation, a trend does not exist for this batch.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 defects or variable defects recorded for the batch that would affect wrap temperature or wrap heating up for use.The complaint intake, triage, and investigation (citi) customizable search and trackwise digital (twd) complaints search were performed.Based on the customizable citi and twd searches, a trend does not exist for the subclass wrap patch pad too hot for lbh 8hr products.Refer to the 36-month trending chart attachment wrap patch pad too.No further action is required.This batch has been reviewed from a manufacturing perspective.There are no known site investigation associated with this batch involving pouch sealing or wrap temperature.

Event Description

On 02-sep-2022, a spontaneous report was received by bridges consumer healthcare from angelini s.P.A.Who received the report on 23-aug-2022.The verbatim of the report is as follows: this serious spontaneous case, manufacturer control number 2022-028453 is an initial report from germany received on (b)(6) 2022 from a pharmacist through diamed (de2136).Follow-up information was received via phone call with the reporting pharmacy on (b)(6) 2022 through diamed regarding the patients age, sex, and symptoms.The information was merged and processed together.This case report concerns an adult female patient (early 20s), who topically applied thermacare heat wraps lower back and hip (batch number ga0178, expiry date unknown) for unknown indication.Concomitant medication were not reported.The patient had previous experience with thermacare and previous use of thermacare was successful.On unknown date, after thermacare heat wraps (lower back and hip) initiation, the patient developed burn blister.The heat wrap got so hot that the consumer suffered a burn blister approximately 1 to 1.5 cm in size underneath the heat wrap.The consumer was not wearing tight clothing which could explain the burn blister.

• 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 ; 4237178579
• MDR Report Key: 15385535
• MDR Text Key: 299556558
• Report Number: 3007593958-2022-00055
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2022
• Device Lot Number: GA0178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• Date Device Manufactured: 10/26/2021
• 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: 20 YR
• Patient Sex: Female