MAUDE Adverse Event Report: ANGELINI THERMACARE JOINT THERAPY 8HR 4CT; HOT OR COLD DISPOSABLE PACK.

Model Number ThermaCare HeatWraps - Flexible

Device Problem Off-Label Use (1494)

Patient Problems Burn(s) (1757); Hypersensitivity/Allergic reaction (1907); Scar Tissue (2060); Vomiting (2144)

Event Date 04/22/2021

Event Type  Injury  

Manufacturer Narrative

The root cause and root cause sub class cannot be identified.There was limited device-specific information provided, not batch number or return sample was available for evaluation.Without a batch reference number or a return sample, a manufacturing and technical evaluation cannot be completed for the wrap involved in this case.There is not a product quality-related trend identified for the subclass adverse event safety request for investigation.The manufacturing operation employ quality control procedures, which include in- process testing, thermal testing, and visual inspection, to ensure the quality of the packaged product.This is an adverse event and misuse for the product "consumer topically applied expired thermacare product.After 3.5 hours, she developed itching at the application site, which progressed to full body itching.She developed raised welts all over body, vomiting, swelling of her hands, face, and ears.Her throat felt dry and she though it swelled and she felt hot.".A risk calculation cannot be determined as there is no reasonable suggestion of a device malfunction.

Event Description

On (b)(6) 2021, a spontaneous report from the united states was received from a consumer regarding a consumer who used the thermacare joint therapy 8hr 4ct (lot number: 20119, expiration date: nov-2017).Medical history included type 2 diabetes, hypertension, seasonal allergies with nasal congestion, and allergies to amoxicillin, penicillin, an unspecified anesthetic medication, and sulfonamides.She had seen an allergist previously.Concomitant products included allegra (fexofenadine) for seasonal allergies, metformin for diabetes, glimepiride for diabetes, lisinopril, and amlodipine, fenofibrate, and metoprolol for hypertension.At 8 pm on (b)(6) 2021, the consumer topically applied the thermacare joint therapy 8hr heat wrap.At approximately 11:30 pm the same night, she developed itching at the application site.The itching progressed to full body itching.She developed raised welts in patches all over her body, vomiting, swelling of her hands, face, and ears.Her throat felt dry and she thought it swelled.She felt hot.For treatment, she took 2 allegra right away.After 45 minutes later, because her symptoms did not improve, she took 4 benadryl (diphenhydramine).She had marks on her skin from scratching.On (b)(6) 2021 it was learned that the consumer spoke to a nurse on a nurse advice line who told her that it was okay to continue to take 4 benadryl at a time.She felt tired from the lack of sleep and the benadryl.It was further reported that the consumer talked to her doctor on friday ((b)(6) 2021), who told her to schedule an appointment with an allergist.The consumer was advised to contact her doctor's office but she did not want to be evaluated since her doctor was new.She had self-diagnosed burns on parts of her body.She stated on her left hand and right side of the leg was where she was scratching and it looked like deep little red scars.For treatment she was applying neosporin, benadryl cream, and a cold compress.Her daughter told her that she sounded nasal.As of (b)(6) 2021, her lips felt a little swollen but her symptoms were otherwise improving.On (b)(6) 2021, the consumer clarified that she did not have a diagnosis of a thermal burn, she just used that term to describe what she felt.That she felt itching, burning, and had red welts.The consumer when asked to further clarify is she experienced a thermal burn she repeated that she did not have a diagnosis but felt itching, burning, and had red welts.As of (b)(6) 2021, the only symptoms that she still experienced was that she occasionally had a dry throat (denied swelling) and a felt reddish blotches on her arms and lets where she scratched welts.She did not know if she would have scarring.She believed that the benadryl and the neosporin ointment have helped.The consumer was not sure if she was going to see an allergist.She did not like the idea of getting poked in any way and she might wait until after the pandemic is over.No additional information was provided.

• Brand Name: THERMACARE JOINT THERAPY 8HR 4CT
• Type of Device: HOT OR COLD DISPOSABLE PACK.
• Manufacturer (Section D): ANGELINI; 1231 wyandotte dr; albany GA 31705
• Manufacturer (Section G): BRIDGES CONSUMER HEALTHCARE; 1100 market street suite 600; chattanooga TN 37402
• Manufacturer Contact: steve weisman ; 1100 market street suite 600; chattanooga, TN 37402 ; 9738891600
• MDR Report Key: 11859827
• MDR Text Key: 262662066
• Report Number: 3007593958-2021-00013
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00305733017241
• UDI-Public: 00305733017241
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: ThermaCare HeatWraps - Flexible
• Device Lot Number: 20119
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 82